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Sr. Process Engineer

Position Overview

This position is a key member of the Aziyo Biologics team and as such develops and assists with: a) new product introduction including technology transfer, commercial-scale process development, validation, and continuous improvements, b) design/selection of equipment, and c) technical studies in support of product characterization.

The responsibilities involve authoring and executing technical protocols and reports – including validation and product characterizations, organizing and analyzing data and test results, troubleshooting and ensuring accurate records of all activities. The Sr. Process Engineer also assists in the transfer of newly developed processes from the development stage to routine production in a manner that is consistent with the goals of Aziyo Biologics and with the Quality Management System. Critical to the role is ensuring compliance with regulatory standards, laws and requirements of requisite agencies by employing appropriate systems/processes.

Position reports to the Manager, Engineering.

Essential Duties & Responsibilities

Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB) and others, as applicable, and adhere to standards and regulations to help the company lead the Biologics industries in quality practices.

Develop and maintain a technical understanding of the company products and general biological and chemical systems utilized by Aziyo Biologics. Understand how the activities performed are controlled by and interact with the Quality System and how they affect the production of tissues.

Generate and maintain the Company’s Master Validation Plan and lead validation activities by initiating, developing, and helping to implement validation projects to ensure processes are capable of consistently meeting their intended specifications and requirements. Develop and manage multiple validations with a focus on establishing robust process validations while achieving cost and timeline objectives.

Design experiments and interpret experimental data generating informed analytical decisions to support validation activities.

Develop, validate, and execute test methodology focused on understanding and/or measuring the biological systems within tissue products.

Create, consult, and contribute to the specification and selection of equipment and processes to facilitate production and test processes.

Facilitate the transfer of projects from Research and Development to routine testing.

Support current manufacturing processes, equipment and tooling for continuous process improvements.

Identify, analyze and correct manufacturing issues to ensure continuous supply of commercial products.

Assist in capability development and certification programs within the organization to develop and train all levels of the organization in the use of OE processes, tools and methodologies.

Education

Bachelor’s degree in Life Sciences or Engineering (or other related technical degree).

Experience and Skills

Minimum of five years of experience in commercial scale biologics, tissue or device manufacturing or technical support

Experience with development of IQ, OQ, PQ and SOPs.

Experience with assay development, execution, and validation desirable.

Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.

Ability to understand and design policies and procedures based on FDA, AATB, and OSHA regulations.

Advanced PC, database and Microsoft Office skills.

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HI, WE’RE BROADLY!

Our product enables local businesses to deliver a five-star customer experience. People have a better experience when the business is responsive, engaged, and customer-centric. By helping local businesses serve their customers better, we also help them thrive.

Our culture is diverse and inclusive and what we all have in common is that we find purpose in our work, we know our work has meaning, and we strive to learn from one another as we build Broadly together!

WHAT'S THE JOB REALLY?

We’re looking for a dedicated product leader - someone who is user-centric and motivated by our mission to help small business owners provide exceptional end-to-end experiences for their customers. As our VP of Product you will report to the CEO and serve as a member of the leadership team, own our product vision and long-term roadmap, scale our product team, and ensure we deliver the best possible product experience for our users to ensure business success.

This position requires highly collaborative cross-functional leadership and close partnership with engineering, sales, customer success, and operations. If you’ve previously held a leadership position at a high-performing SaaS company, managed a product team, and have a passion for helping small business owners, this job is for you!

You will:


  • Own and drive the company’s product roadmap and vision, and work with leadership to ensure that (quarterly/annual) strategic plans lead to business success and reflect the needs and interests of our users

  • Be a driving force in the company’s leadership team by leading with charisma and empathy, a user-centric approach, a bias toward action, and a philosophy of inclusiveness, transparency, and employee empowerment

  • Lead and develop a high-performing team in engineering, product management, product marketing, design, and user research, while building an inclusive, empathetic, and user-focused management team

  • Consistently and reliably ship product in a fast-paced and iterative development environment

  • Measure the success and impact of releases and product development with clearly defined goals and measurable metrics

  • Incorporate both quantitative and qualitative research into the product process, using this data for decision-making, prioritization, and product growth

  • Facilitate product discovery, and validation with customers, by generating hypotheses and new concept ideas, and conducting user research using a wide variety of methods (surveys, interviews, user testing, etc.)

  • Work cross-functionally with Sales, Customer Success, and Operations to build, sustain, and scale a rapidly growing product

Requirements:


  • 5+ years of product team and executive experience

  • Excellent communication skills and ability to build relationships of empathy, trust, and respect with other team members, customers, and partners

  • Demonstrated ability to work closely and collaboratively with cross-functional teams, and ability to find effective outcomes between parties by influencing and building consensus

  • Exceptional prioritization and project management skills

  • Proven track record of shipping successful products and features into a production environment

Benefits:


  • Flexible Time Off: We believe that balance between work and life is essential to happiness and success, so work hard and take the time you need

  • Health Coverage: We offer competitive coverage plans for medical, dental and vision, because you’re worth it

  • Food: We serve catered lunch every week, host company get-togethers, and stock the office with bountiful snacks

  • Fitness: Gym subsidy, commuter benefit

  • Travel: Ask us about our International Travel Stipend

  • Team Bonding: Team Outings, Regular Meet'n'Greets,, Quarterly All-Hands, Team off-sites and more!

  • Compensation: Salary, Bonus, Equity DOE

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company backgroundChef Koochooloo is a web + mobile + social + educationalplatform that teaches kids about math, science and cultural sensitivity through a cooking technologyplatform and enrichment program. We are grant funded, with a non-profit division,and we have a passion for making games that will stimulate, entertain, and leave a lasting, positive impression. We pride ourselves on contributing to the local community and creating a positive impact on the environment.About the jobAre you passionate about creating a fun and educational experience for children? Do you love cookingand tasting recipes from different countries?You will be working on helping to create an innovative tech solution that uses Machine Learning techniques to deliver an adaptive learning curriculum that is both effective and highly engaging to students .. Your research could make a huge difference to many verticals: educational curriculum improvement, healthy nutrition, and children’s health.What can you expect?


  • An unmatched environment in which to develop your knowledge of building early-stage tech startups,

not just from the tech perspective, but from a wider business perspective


  • Hands-on software development, where you can apply your skills, knowledge & experience across a

range of sectors, business models, and products


  • Time split between early concept development (where throw-away prototyping dominates) and product

development (where the focus is on building the tech foundation for the new business)


  • All the benefits of the startup world (innovation, ownership, pace, etc).

Responsibilities


  • Participate in research in Artificial Intelligence and Machine Learning applications.

  • Develop solutions for real-world problems

  • Data gathering

Minimum Qualifications:


  • PhD degree in Computer Science

  • Experience contributing to research communities and/or efforts, including publications at conferences

(such as CVPR, ICCV, ECCV, NeurIPS, ICML, ICLR, etc.), citations, etc.


  • Experience in Natural Language Understanding, Computer Vision, Machine Learning, Algorithmic

Foundations of Optimization, Data Mining, or Machine Intelligence.


  • Programming experience in one or more of the following: Ruby on Rails, C++, C#, Haxe, and/or

JavaScript.Preferred Qualifications:


  • Large Scale Machine Learning experience

  • Experience with Deep Learning, Neural Networks, or related Machine Learning techniques

  • Ability to be innovative, combined with strong communication skills

  • Demonstrated problem-solving skills

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Job Description


Job Description


IAG Aero Group is seeking a Chief Information Officer to be responsible for developing and governing our data and information strategy in order to drive business decisions and growth. You will develop data procedures and policies, and work closely with various departments to collect, prepare, organize, protect and analyze data assets while ensuring that the company meets industry best practices. Other duties will include leading inter-disciplinary teams, improving and streamlining data systems within the company, and driving innovation.


The successful candidate will have a proven track record in data management, leadership and information technology systems and tools. A strong background in IT, business and mathematics is advantageous.


 


Responsibilities:



  • Thorough understanding of the business and data strategy.

  • Designing and implementing data strategies and systems across IAG’s International companies

  • Lead, motivate and manage technical teams.

  • Overseeing the collection, storage, management, quality and protection of the companies data.

  • Implementing data privacy policies and complying with data protection regulations.

  • Determine where to cut costs and increase revenue based on insights derived from data.

  • Effectively communicate the status, value, and importance of data collection to staff

  • Knowledge of relevant applications, big data solutions, and tools.


 


Requirements:



  • Bachelor's Degree in Information Technology or related field.

  • Master's Degree preferred.

  • Experience with ERP platforms, Quantum and Business 365 preferred

  • 5 to 10 years' experience in a senior-level data management role.

  • Management experience.

  • Strong leadership and communication skills.

  • Project management skills.

  • Analytically minded.

  • Professionalism and ethical behavior.


 



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** PLEASE NOTE THIS IS NOT AN INFORMATION TECHNOLOGY ROLE **


In a continuing effort to focus on the development of best in class technical solutions for our customers and end-users worldwide, MD Helicopters (MDHI) seeks to fill a role for an Aerospace Head of Engineering/Chief Technology Officer. This executive position will be responsible for leading all Research and Development (R&D) activities for MDHI, a Helicopter OEM. The role is responsible for leading MDHI’s innovation efforts by developing the current and future product portfolio of MDHI. This individual will be directly involved with invention, design and development, sourcing strategy, manufacturing strategy, customer requirements and quality assurance. The Chief Technology Officer will be an industry expert and liaise with groups and stakeholders internal and external to the business to ensure policies and programs are developed in accordance with relevant industry standards and governmental regulations.


DUTIES AND RESPONSIBILITIES include the following:


• Maintains detailed knowledge and insight about the aerospace market, technology trends, and has a complete understanding of customer needs.

• Becomes a leader in advancing new technology tools to include, but not limited to; software simulation, 3D printing with composites, as well as virtual reality for evaluation, assessment and testing.

• Maintains good relationships with key customers. Has access to high engineering and pre-development levels with customers to gain first-hand information about proposed future product requirements and, in the process, promotes MDHI’s product solutions and capabilities.

• Is accountable for the entire value stream of R&D/innovation from product development to market launch activities.

• Develops, introduces, and maintains most efficient R&D processes focused on cost and customer satisfaction.

• Develops, introduces and maintains strategically benchmarked processes to ensure market competitiveness, an understanding of trends, and detailed knowledge of competitor products and processes.

• Reports frequently on the status of innovation and R&D activities to the management team.

• Engages senior management in the development process of new products.

• Maintains responsibility for the global engineering budget and ensures alignment on spending with business strategy and goals.

• Interviews, selects, and hires qualified individuals for key management positions.


SUPERVISORY RESPONSIBILITIES


Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.


SKILLS AND ABILITIES



  • Develop and implement strategic initiatives and solutions to fulfill the R&D Strategic Plan.

  • Lead, direct, and control development projects to include planning, defining requirements and budget, systems design, programming, and controls, analysis testing.

  • Demonstrated leadership and implementation of lean methodologies in a manufacturing environment.

  • Demonstrated strong leadership, collaboration, project management, problem-solving, change management and influencing skills.

  • Comfortable and well-practiced leading teams within a global matrix with virtual team relationships.

  • Experience serving as a technical advisor to a senior leadership team.

  • Demonstrated and effective communication and relationship building skills at all levels in an organization.

  • Superior communication skills and can present his/her ideas in a clear, concise manner; one who can adapt his/her communication style as needed.

  • Unquestioned integrity and values that the organization can trust without reservation.

  • Consensus builder with strong persuasion skills.

  • A highly motivated team player who contributes to an atmosphere in which people work together, enthusiastically and effectively, to produce results.

  • A good listener.

  • Must be flexible with the ability to change, adapt and grow – patience and diplomacy skills are critical to success, particularly with customers.

  • Exhibits passion for the MDHI’s mission.


EDUCATION and/or EXPERIENCE



  • Bachelor’s Degree in Engineering or another technical discipline. Master’s level degree in a scientific discipline or MBA a plus. PHD a plus.

  • Minimum of 10 years of related experience in senior level engineering and R&D leadership.

  • Fixed or Rotor Wing industry experience required.

  • Demonstrated understanding of R&D principles.

  • Assignments require considerable knowledge of management practice and policy interpretation or some combination of education and experience that would enable senior technical capability allowing the incumbent to independently evaluate, select, and apply techniques and standards.

  • Strategic planning and budgeting experience.


This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

This document does not create an employment contracts, implied or otherwise, other than an “at will” relationship.


CERTIFICATES, LICENSES, REGISTRATIONS


None


WORK ENVIRONMENT/PHYSICAL DEMANDS


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Work performed in an office and factory settings.

  • Exposure to shop environment such as noise, dust, odors and fumes.

  • Occasionally required to lift up to 20 lbs.

  • Regularly required to sit, stand, bend, reach and move about facilities.


A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

MD Helicopters, Inc. is an equal employment employer and is committed to providing employment opportunities to minorities, females, veterans, and disabled individuals.


See full job description

** PLEASE NOTE THIS IS NOT AN INFORMATION TECHNOLOGY ROLE **In a continuing effort to focus on the development of best in class technical solutions for our customers and end-users worldwide, MD Helicopters (MDHI) seeks to fill a role for an Aerospace Head of Engineering/Chief Technology Officer. This executive position will be responsible for leading all Research and Development (R&D) activities for MDHI, a Helicopter OEM. The role is responsible for leading MDHI’s innovation efforts by developing the current and future product portfolio of MDHI. This individual will be directly involved with invention, design and development, sourcing strategy, manufacturing strategy, customer requirements and quality assurance. The Chief Technology Officer will be an industry expert and liaise with groups and stakeholders internal and external to the business to ensure policies and programs are developed in accordance with relevant industry standards and governmental regulations.DUTIES AND RESPONSIBILITIES include the following:• Maintains detailed knowledge and insight about the aerospace market, technology trends, and has a complete understanding of customer needs.• Becomes a leader in advancing new technology tools to include, but not limited to; software simulation, 3D printing with composites, as well as virtual reality for evaluation, assessment and testing.• Maintains good relationships with key customers. Has access to high engineering and pre-development levels with customers to gain first-hand information about proposed future product requirements and, in the process, promotes MDHI’s product solutions and capabilities.• Is accountable for the entire value stream of R&D/innovation from product development to market launch activities.• Develops, introduces, and maintains most efficient R&D processes focused on cost and customer satisfaction.• Develops, introduces and maintains strategically benchmarked processes to ensure market competitiveness, an understanding of trends, and detailed knowledge of competitor products and processes.• Reports frequently on the status of innovation and R&D activities to the management team.• Engages senior management in the development process of new products.• Maintains responsibility for the global engineering budget and ensures alignment on spending with business strategy and goals.• Interviews, selects, and hires qualified individuals for key management positions.SUPERVISORY RESPONSIBILITIESCarries out supervisory responsibilities in accordance with the organization's policies and applicable laws.SKILLS AND ABILITIESDevelop and implement strategic initiatives and solutions to fulfill the R&D Strategic Plan.Lead, direct, and control development projects to include planning, defining requirements and budget, systems design, programming, and controls, analysis testing.Demonstrated leadership and implementation of lean methodologies in a manufacturing environment.Demonstrated strong leadership, collaboration, project management, problem-solving, change management and influencing skills.Comfortable and well-practiced leading teams within a global matrix with virtual team relationships.Experience serving as a technical advisor to a senior leadership team.Demonstrated and effective communication and relationship building skills at all levels in an organization.Superior communication skills and can present his/her ideas in a clear, concise manner; one who can adapt his/her communication style as needed.Unquestioned integrity and values that the organization can trust without reservation.Consensus builder with strong persuasion skills.A highly motivated team player who contributes to an atmosphere in which people work together, enthusiastically and effectively, to produce results.A good listener.Must be flexible with the ability to change, adapt and grow – patience and diplomacy skills are critical to success, particularly with customers.Exhibits passion for the MDHI’s mission.EDUCATION and/or EXPERIENCEBachelor’s Degree in Engineering or another technical discipline. Master’s level degree in a scientific discipline or MBA a plus. PHD a plus.Minimum of 10 years of related experience in senior level engineering and R&D leadership.Fixed or Rotor Wing industry experience required.Demonstrated understanding of R&D principles.Assignments require considerable knowledge of management practice and policy interpretation or some combination of education and experience that would enable senior technical capability allowing the incumbent to independently evaluate, select, and apply techniques and standards.Strategic planning and budgeting experience.This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.This document does not create an employment contracts, implied or otherwise, other than an “at will” relationship.CERTIFICATES, LICENSES, REGISTRATIONSNoneWORK ENVIRONMENT/PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work performed in an office and factory settings.Exposure to shop environment such as noise, dust, odors and fumes.Occasionally required to lift up to 20 lbs.Regularly required to sit, stand, bend, reach and move about facilities.A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.MD Helicopters, Inc. is an equal employment employer and is committed to providing employment opportunities to minorities, females, veterans, and disabled individuals.


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