Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical
About The Position
The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global-human-health portfolio and closely partner with various Packaging or Device Technology engineering groups, packaging sites, and partner analytical groups. The CPDA is located at our Company’s large research and manufacturing West Point, PA location, where our packaging & device laboratories are established. The CPDA is seeking an Associate Principal Scientist/Engineer who, as an individual contributor, can act as an MDCP analytical lead for one or more exciting projects. A key aspect of the role is leadership, within a cross-functional working group, to develop & own both an analytical strategy (to satisfy Design Controls inputs) as well as the timeline, which includes managing analytical efforts. The role will naturally include substantial technical creative challenge for Device Characterization and more formal Design Verification, which includes development & validation of mechanical test methods as well as coordination & technical oversight for internal CPDA staff or external lab testing (where required) to meet project timelines and deliverables. To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices, as well as be a highly effective communicator (written and verbal), collaborator and technical coach. Ideally, the candidate has prior hands-on analytical experience with MDCP and Design Controls.
Requirements
- Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent field)
- A minimum of 3 years with Ph.D. in a role responsible for medical device or combination product development verification, method development and testing.
- Experience with mechanical testing, imaging, and measurement equipment and techniques. Including (but not limited to) tensile/compression/torsional testing, materials characterization, x-ray computed tomography, rheometry, and microscopy.
- Excellent collaboration and leadership skills, to work as part of cross-functional teams to meet project timelines and deliverables.
- Analytical Chemistry
- Computed Tomography (CT)
- Cross-Cultural Awareness
- Design Validations
- Design Verification
- Design Verification Testing
- Device Characterization
- Interdisciplinary Collaboration
- Materials Characterization
- Mechanical Testing
- Medical Devices Engineering
- Microscopies
- Professional Networking
- Rheometry
- Tensile Strength Testing
- Tomography
- X Ray Imaging
Nice To Haves
- Experience developing innovative Device Characterization and Design Verification (DV) strategies/mechanical tests with validations, incl. engineering studies, design verification protocols, stability studies and validation protocols, with appropriate selection of acceptance criteria.
- Experience with medical device development with understanding/familiarity of Design Controls (21 CFR 820.30) and relevant industry standards.
Responsibilities
- Act as an MDCP analytical lead for one or more exciting projects.
- Develop and own an analytical strategy (to satisfy Design Controls inputs) as well as the timeline, which includes managing analytical efforts.
- Provide technical creative challenge for Device Characterization and more formal Design Verification.
- Develop and validate mechanical test methods.
- Coordinate and provide technical oversight for internal CPDA staff or external lab testing (where required) to meet project timelines and deliverables.
- Be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices.
- Be a highly effective communicator (written and verbal), collaborator and technical coach.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
