Job Description
Job Description
Required Qualifications:
- BS in Mechanical, Biomedical, or mechanically‐leaning Chemical Engineering and 5–10 years total experience (at least 5 years in medical devices) with design control and process development.
- Demonstrated ownership of process validation (TMV, OQ/PQ) and process characterization, including authoring/executing protocols and compiling compliant reports.
- Proven, hands‐on ability to design/commission equipment, tooling, and fixtures and to translate blank‐sheet concepts into manufacturable processes.
- Proficiency with statistics and data analysis (e.g., Minitab, Excel)—including MSA, ANOVA, and capability analysis—and strong documentation skills (BOMs, routers, FMEAs).
- Strong cross‐functional communication and teamwork on large programs; able to lead work independently, operate primarily onsite, and travel ~10% as needed.
Preferred Skills and Experience:
- Experience with catheter assembly and finished‐device manufacturing (e.g., extrusion/shaft builds and multi‐component assemblies) in vascular therapies.
- Track record transferring processes to production, including development builds, DFM input, and qualified production line start‐up.
- Familiarity with PDP/TDP, document control (e.g., Windchill), and IP generation or contributions.
- Background in R&D‐leaning environments or startups, comfortably wearing multiple hats across DV, PV/NPI, and manufacturing support.
- Experience mentoring technicians/engineers, leading technical reviews, and collaborating with suppliers/contract manufacturers and global plants.
Day to Day:
As a Senior Engineer III, you will lead end‐to‐end process development for new medical device products—moving from design verification into full process validation—while partnering closely with R&D, Quality, Manufacturing, Regulatory, and suppliers across a large, cross‐functional team. Day to day, you’ll develop and mature manufacturing processes, design and commission equipment, fixtures, and tooling, and independently own validation deliverables such as process characterization, TMVs, and OQ/PQ within PDP/TDP and quality system frameworks. You’ll support development builds, provide DFM input to the print package, qualify production lines, and help transfer robust, statistically capable processes into manufacturing—often for catheter and finished‐device assemblies within vascular therapies. The role blends system engineering, hands‐on technical problem solving, and statistical analysis (Minitab/Excel) with a team‐first, humble, highly collaborative culture, and may include mentoring technicians and junior engineers while contributing to technical strategy and IP