Engineer III, Device Development

AstraZeneca • New Haven, CT

1d • $97,000 - $146,000

About The Position

This position will serve the role of Engineer III for device development / human factors engineering within the Alexion Device Development organization. The role will support the human factors workstreams for pipeline products as well as lifecycle management. This role will interact with multiple functional teams including Device Development, Clinical, Commercial/Marketing, Quality, and Regulatory, clinical development through registration and commercial product 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. Support core teams to develop and support the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products. Support design validation activities including summative human factors study (i.e. human factors validation) from protocol development, study execution, and reporting. Provide input and/or author for user need identification and user interface specifications development. Provide input to use-related risk management activities such as known use problem analysis, hazard analysis, and use-related risks analysis Draw learnings from competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging) Interface with human factors firms (vendors) and manage their activities for a formative or summative human factors study. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers. Ensure all human factors engineering activities as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements. Support feasibility activity of device assessment (e.g., testing, fixturing, protocol, report). You will need to have: Experience in human factors engineering and exposure to design and development of medical device and combination products. Experience in design control activities. Ability to manage external human factors firms (vendors). Strong communication and collaboration skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations. Knowledge of human factor/usability engineering, safety, performance and regulatory compliance requirements of medical device and combination products (e.g. IEC 62366, FDA HF guidances, EU Regulation 2017/745 (MDR)). [For office-based positions:] As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: BS Degree & 6+ years of experience OR MS Degree & 3+ years of experience in Engineering (Biomedical, Chemical, Mechanical, Electrical Engineering, Human Factors or related subject) Professional experience in Medical Device, Human Factors Development, Design control or related work experience required. Experience with injection based combination product development and risk management preferred. Experience with graphics design a plus.

Requirements

• Experience in human factors engineering and exposure to design and development of medical device and combination products.
• Experience in design control activities.
• Ability to manage external human factors firms (vendors).
• Strong communication and collaboration skills; ability to connect with all levels of the organization.
• Proficient in writing internal reports, project summaries, and internal/external presentations.
• Knowledge of human factor/usability engineering, safety, performance and regulatory compliance requirements of medical device and combination products (e.g. IEC 62366, FDA HF guidances, EU Regulation 2017/745 (MDR)).
• As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice To Haves

• BS Degree & 6+ years of experience OR MS Degree & 3+ years of experience in Engineering (Biomedical, Chemical, Mechanical, Electrical Engineering, Human Factors or related subject)
• Professional experience in Medical Device, Human Factors Development, Design control or related work experience required.
• Experience with injection based combination product development and risk management preferred.
• Experience with graphics design a plus.

Responsibilities

• 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.
• Support core teams to develop and support the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.
• Support design validation activities including summative human factors study (i.e. human factors validation) from protocol development, study execution, and reporting.
• Provide input and/or author for user need identification and user interface specifications development.
• Provide input to use-related risk management activities such as known use problem analysis, hazard analysis, and use-related risks analysis
• Draw learnings from competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
• Interface with human factors firms (vendors) and manage their activities for a formative or summative human factors study.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Ensure all human factors engineering activities as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
• Support feasibility activity of device assessment (e.g., testing, fixturing, protocol, report).

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level