Regeneron is seeking an experienced and strategic Combination Products Sustaining Engineer to manage a team in addition to monitor, investigate, maintain and/or improve the quality and performance of commercial combination products. They will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external stakeholders, for the maintenance of commercial products.
A typical day for a Manager Sustaining Engineering might include:
Implementing design changes to improve the quality of existing products and/or the customer experience.
Assisting with customer complaint investigations to identify root cause.
Performing design change assessments for changes to existing products.
Maintaining Risk Management Files for existing products based on post marketing surveillance and manufacturing events.
Facilitating design transfer of existing products to new manufacturing sites.
Performing technical evaluations related to supplier and manufacturing changes.
Integrating identified product performance enhancements to new product development.
Providing technical guidance to sustaining engineers.
Participating in cross-functional design teams to address design issues.
Developing and maintaining key business partner relationships throughout Regeneron.
This role might be for you if you:
Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
Have experience with design history file management (21 CFR 820.30).
Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities.
Can balance business objectives with technical constraints.
Can work effectively across multiple functional teams.
Seek out continuous improvements and collaborative opportunities to improve internal processes and stakeholder relationships.
Have strong technical writing and oral communication skills.
Targeted to have direct reports within the Sustaining Engineering organization, to support multiple combination products in commercial distribution.
To be considered for the Manager Sustaining Engineering you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Engineering; Biomedical Engineering, Mechanical Engineering, Industrial Engineering is preferred.. For various levels you must have the following:
Associate Manager Sustaining Engineering: 6+years of relevant experience
Manager Sustaining Engineering: 7+ years of relevant experience
Previous experience in manufacturing of medical devices and/or combination products is preferred. Previous supervisory/ people leadership experience is required. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$103,300.00 - $197,500.00