Senior Device Development Engineer

Regeneron Pharmaceuticals • Valley, AL

1d • $66,200 - $143,900

About The Position

The Senior Device Development Engineer executes combination product development projects, with responsibilities that may include project leadership, technical product engineering, design transfer, and secondary packaging. The role works closely with cross-functional teams to ensure project success and uses engineering analysis to help ensure products developed internally and externally are technically robust, perform sufficiently, and operate reliably. The engineer identifies project risks, promptly escalates issues, and proposes solutions. Work must comply with applicable regulations and industry standards, while supporting continuous improvement focused on product safety and efficacy and timely delivery of commitments. The role also represents IOPS and the devices group at relevant industry meetings and forums.

Requirements

• Bachelor of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field, or an equivalent combination of education and experience.
• For the Senior Engineer level, 5 or more years of experience in product development or engineering, or an equivalent combination of education and experience.
• Medical device industry experience is required for the Senior Engineer level.
• Experience developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required for the Senior Engineer level.

Nice To Haves

• Medical device industry experience is preferred for the Engineer level.
• Experience developing regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is preferred for the Engineer level.

Responsibilities

• Execute combination product development projects on time, within scope, and within budget, with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging.
• Work closely with cross-functional teams to support project success.
• Use engineering analysis to ensure products developed internally and externally are technically robust and perform sufficiently and reliably.
• Identify project risks, escalate issues and risks promptly, and actively propose solutions.
• Ensure work activities comply with applicable regulations and industry standards.
• Promote continuous improvement focused on product safety and efficacy and accelerating delivery of commitments.
• Represent IOPS and the devices group at appropriate industry meetings and forums.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match, depending on country and role.
• Health and wellness programs, depending on country and role.
• Fitness centers, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off, depending on country and role.
• Family support benefits, depending on country and role.

What This Job Offers

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