R&D DESIGN ENGINEER

Design products, prototypes, equipment or fixtures for medical device applications.
Operate processing equipment in a specific process area, including but not limited to mechanical testing equipment and machining support equipment.
Design experiments to provide data based conclusion about a process or product performance.
Perform/coordinate characterization testing as needed for part characterization (ex. mechanical testing) and communicate results to project stakeholders.
Procure and implement new testing and manufacturing equipment using IQ/OQ/PQ validation techniques.
Conduct/support process development activities.
Assist in project tasks planning, management, coordination and execution.
Using GDP practices, maintain laboratory notebook and write technical reports detailing procedures, outcomes, and observations.
Assist in creation of publishable research findings in the form of abstracts, papers and grants.
Recommend and rationalize specifications for development products.
Support patent filing and claims.
Interface with cross-functional team members to develop specifications, coordinate prototype fabrication, and transition medical device prototypes into manufactured components.

Required/Preferable Knowledge, Skills and Abilities for the Role:

• Prior experience with medical and/or pharmaceutical grade materials preferred, especially bioabsorbable/bioresorbable materials.
• Prior experience with polymeric synthesis techniques and associated equipment.
• Prior experience with polymer processing and associated equipment (extrusion, solvent casting, dip coating, mixing, etc.)
• Prior experience with material characterization analytical techniques as inputs for process development and characterization (UV VIS, NMR, FTIR, GC, rheology, GPC, HPLC etc.).
• Prior experience with prototype characterization techniques (surface profilometry, microscopy, 3D scanning, etc.).
• Prior hands-on experience with mechanical testing equipment, fixture design, and test method execution.
• Prior hands-on experience with 3D CAD design software (including, but not limited to, SOLIDWORKS).
• Prior experience in 3D printer operation, tuning, and maintenance (VP, FFF, etc.)
• Prior experience with cell culture and associated in vitro analysis techniques.
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
• Prior experience with performing test methods in accordance with USP, FDA, ISO and/or ASTM standards.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab.
• Understanding of cause-effect relationship between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.
• Good written and verbal communication skills, particularly for team communications.