Senior Device Development Engineer
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: Execute to combination product development projects with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Executes to combination product development projects on time, in scope, and within budget with responsibilities in project leadership, technical product engineering, design transfer, and/or secondary packaging
• Works closely with cross-functional team to assure project success
• Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably
• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions
• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards
• Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments
• Represents IOPS and the devices group at appropriate industry meetings and forums
Knowledge, Skills and Abilities:
• Ability to maintain integrity and honesty at all times
• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Continuously drive to improve processes for improved performance
• Demonstrate respectful behavior at all times
• Makes quality decisions with limited supervision
• Sets priorities
• Ability to write advanced reports
• May own or lead a project
• May mentor others and/or have direct reports
• Ability to work in an ever-changing environment
• Builds strong working relationships cross-functionally
• Communicates with transparency and active listening
Education and Experience:
• Bachelors of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required
• 5 or more years of experience in product development or engineering is required
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971 is required
• Experience in the medical device industry is preferred
Note: The level of the position offered (Engineer / Senior Engineer / Principal Engineer) will be determined by the amount of relevant experience of the candidate to the role.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.