Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical Full-time

Associate Principal Scientist/Engineer

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.

Required Education, Experience, and Skills:

Education Requirement (minimum):

• Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent field)

Required Experience:

• A minimum of 3 years with Ph.D. in a role responsible for medical device or combination product development verification, method development and testing.
• Expertise in mechanical testing and analysis, solid-state imaging and materials characterization—such as tensile/compression/torsional testing, multibody dynamic FEA, x-ray computed tomography, microscopy & image analysis, and rheology.
• Excellent collaboration and leadership skills, to work as part of cross-functional teams to meet project timelines and deliverables.

Preferred Experience:

• Experience developing innovative Device Characterization and Design Verification (DV) strategies/mechanical tests with validations, including 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.