Sr. Medical Device Engineer (Lab)

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 products projects with responsibilities in test method development and validation and design verification and validation.

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 to identify new device and drug product test methods in support of product characterization and design verification.

• Generates documentation needed to support characterization, method development, method validation, and device design verification testing activities.

• Fabricates and/or procures engineering prototypes, equipment and custom fixtures to support development of new product designs.

• Facilitates transfer of newly developed physical test methods to internal and external QC functions as needed to support design transfer activities.

• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions

• Works closely with cross-functional team to assure project success

• Maintain, troubleshoot and facilitate the repair of assigned laboratory/machine shop equipment and associated logbooks

• Document deviations, perform investigations, and implement corrective/preventive actions as required.

• Assures work activities are conducted in a manner compliant with all applicable regulations, industry standards, EHS policies and Regeneron policies

• 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 & 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

#LI-KS1

Education and Experience:

• Senior Level: Bachelors of Science in engineering discipline is required plus 5+ years of experience, or Master of Science in engineering discipline plus 4+ years of experience, or Doctor of Philospohy in engineering discipline.

• Principal Level: Bachelors of Science in engineering discipline is required plus 8+ years of experience, or Master of Science in engineering discipline plus 7+ years of experience, or Doctor of Philospohy in engineering discipline plus 2+ years of experience.

• Experience writing technical documents such as test reports, technical memos, test protocols, input requirements documents is required.

• Experience in the medical device industry is preferred.

• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971 is preferred.
Experience with patch pumps or infusion pumps preferred

Note: The level of the position offered - Senior, Principal, etc. - 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.