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6

Sr. Engineer, Device Development

6ojdnwl51xr1edi9opowmwpavnqnq2021bhjsjg7i638q9b533pr3sgvl6uhqrvc · 30+ days ago

Boston, MA, US

$97k+
Estimation

Full-time

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This is what you will do:
This position will serve the role of Sr Engineer 2 for Human Factors of combination products within Global Product Development. The candidate will participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle management. This position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and HF vendor selection. This role will interact with multiple functional teams including Clinical, Global Drug Safety, Marketing, Quality, and Regulatory, from clinical development through registration and commercial support.

You will be responsible for:

Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market.
Member of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.
Lead user related risk analysis for the programs under development.
Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
Educate team members and other internal stakeholders on the Human Factors development process and approach
Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.
Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
Ensure all human factors engineering comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

You will need to have:

Experience in commercialization of medical device and/or combination products.
Deep knowledge of regulatory and compliance requirements for device risk management and human factors/usability engineering for combination product.
Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management.
Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms.
Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations.
Deep knowledge of human factor/usability engineering, safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA HF guidance).

We would prefer for you to have:
Bachelor’s in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 years experience or Master’s / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 8 to 10 year experience in medical device development in Ergonomics and Human Experience with injector based combination product preferred

At Innovative Development, LLC we value our employees and invest in their personal and professional growth. We offer comprehensive Medical, Dental and Vision options along with fully paid Life, Disability and Accident insurance. Our Employer matched 401(k) enables us to invest in your financial future, while our personalized Leadership Development program helps you thrive in your professional environment. In this fast-changing world, we prioritize mental health through our Employee Assistance Programs. We also encourage work/life balance by offering a variety of working arrangements, including remote, in-person, and hybrid. Join Innovative Development, LLC and develop your potential!

Benefits Highlights:

PTO
Medical, Dental, and Vision. Health Savings accounts for qualified expenses under HSA plans
Teledoc, Weight Loss and Wellness Plans included with Health Plans
Employee Assistance Programs including Mental Health
Employer paid life insurance
Employer paid Long and Short Term Disability Coverage
401(k)/Roth IRA with Employer Matching
Personalized Leadership Development Program
Volunteer and Community Events
Opportunity for growth

•

Last updated on Nov 9, 2023

About the company

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6ojdnwl51xr1edi9opowmwpavnqnq2021bhjsjg7i638q9b533pr3sgvl6uhqrvc

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