Staff Process Engineer

Staff Process Engineer – Baylis Medical Technologies Position OverviewWe are seeking a Staff Process Engineer to join our catheter development team. The ideal candidate will build new prototypes and develop next‑generation processes for medical devices, while mentoring junior engineers and ensuring regulatory compliance. Key Responsibilities Develop manufacturing processes from concept to prototype. Lead process development projects and validate designs in R&D or commercial production (IQ, OQ, PQ, PV&V). Manufacture and test prototypes, applying lean manufacturing, DOE, and statistical methods. Work with external vendors to develop new process technologies, materials, and equipment. Set up new manufacturing equipment and production lines, design and source tooling. Document process knowledge, including databases of new manufacturing and inspection technologies. Apply simulation and statistical analysis to aid in device design. Research new processes to meet product specifications and cost metrics. Evaluate processes and design alternatives, ensuring health‑and‑safety compliance. Develop and maintain PFMEAs to identify and mitigate process risks. Lead process validation and equipment qualification, supporting and mentoring junior engineers. Adhere to corporate, quality, and health‑and‑safety policies. Required Qualifications Bachelor’s degree in Engineering or related field. 3‑5 years of experience in manufacturing process design and optimization in the medical device industry. Deep understanding of one or more catheter manufacturing technologies (e.g., jacket reflow, RF tipping, hydrophilic coating, coiling). Practical experience with analytical instruments (DSC, DMA, laser micrometer, dimensional measurement tools, tensile, torque, kink resistance testing). Experience with Six Sigma methodology and statistical analysis using Minitab, Python, or Monte Carlo simulation software. Proficiency in CAD design (SolidWorks) for fixture design. Knowledge of material joining, cutting, and forming methods for materials such as stainless steel, PEBAX, Nylon, PTFE, FEP, PET, PEEK, TPU and hydrophilic/hydrophobic coatings. Experience with test method validation and process validation (IQ, OQ, PQ, PPQ). Experience working with external vendors to develop new materials and custom manufacturing equipment. Preferred Asset Skills Master’s or Ph.D. in material science, polymer science, metallurgical engineering, biomedical engineering, or mechanical engineering. 3+ years in the catheter‑based medical device industry. Deep understanding of braiding, laser cutting of stainless steel or nitinol hypotube. Proficiency with advanced analytical instruments (SEM, EDX, FTIR, UV‑Vis, surface energy tester). Experience with 3D printing, injection molding, or machining. Experience with vision systems for production inspection. Proven track record leading process development from idea to working prototype. Benefits & Perks Sponsored shuttle service and subsidized transit options for a hassle‑free commute. Hybrid work model with flexible hours for work‑life integration. One dedicated day off for impactful volunteering. Robust career development opportunities including on‑site training and workshops. Comprehensive rewards package: tuition reimbursement, health spending account, and other benefits. Vibrant workplace culture with employee‑led clubs, sports teams, and regular social events. How to Apply Apply directly through our careers page or by sending your resume to careers@baylis-medical.com. We encourage early application—we are looking for talented individuals ready to make a meaningful impact. Baylis Medical Technologies is an equal‑opportunity employer and encourages applications from all qualified individuals. Please inform us if you require accommodations during the recruitment process. #J-18808-Ljbffr