5+ YOE5+ years in medical device process development/validation, Bachelors in engineering, experience with catheter/sheath manufacturing, process characterization, IQ/OQ/PQ validation, GMP/ISO 13485 knowledge, strong problem solving and documentation skills.
5+ YOEBachelor's in Engineering, 5+ years in process development/manufacturing engineering for Class III medical devices, experience with IQ/OQ/PQ/PPQ, design transfer, FDA/ISO/EU regulatory knowledge, fixture design and automation, strong documentation and communication skills.
Ascential Technologies: Designs and manufactures automated testing and assembly equipment.
1+ YOEBachelors in engineering (biomedical/mechanical) required; preferably 1-3 years engineering experience. Experience with equipment qualification and computer system validation preferred. Proficiency with MS Office, strong problem solving, ISO/FDA knowledge, and communication skills.
Experience in process development, manufacturing engineering, validation, characterization, equipment qualification, continuous improvement, troubleshooting, and scale-up within regulated industries; familiarity with design controls, risk management, process validation, and FDA/ISO environments.
Engineer II, Process Development, R&D (Maple Grove, MN, US)
Maple Grove, Minnesota, United States
$79k-$119k/yrOnsiteFull Time
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
2+ YOEBA/BS in Engineering or physical sciences; 2+ years experience; travel up to 25%; DFMEA/PFMEA experience; Minitab; process design and development.
Smith & NephewLondon Stock Exchange: SN: Develops medical equipment for tissue repair, regeneration, and replacement.
0+ YOEBachelor's in engineering required; 0–2 years manufacturing engineering experience; SolidWorks preferred; familiarity with regulated medical device environments, Lean/DMAIC, process development and validation.
IntegerNYSE: ITGR: Manufactures medical devices and components for global healthcare companies.
5+ YOENPI-focused engineer to develop, validate, and improve processes for new product introductions; apply statistics; ensure quality systems compliance.
rms Company: Contract manufacturer of high-precision medical device components and implants.
7+ YOELead development of metal additive manufacturing processes for medical devices; design and validate AM workflows; ensure FDA/ISO compliance; cross-functional collaboration.
AspenTech: Provides industrial software for asset optimization and process simulation.
4+ YOEBachelor's in CS/Applied Math or related, 4+ years back-end development experience (C/C++ preferred), experience with APIs and daemon processes, strong analytical and communication skills, and legal authorization to work in the U.S.
Experience in medical device design/development, systems engineering, catheter-based technologies, tissue engineering, sustaining engineering, PLM, V&V, and risk management; familiar with regulated (FDA/ISO) Class III device processes.
Standard Iron: Manufactures custom metal components and assemblies for industrial equipment.
3+ YOE3+ years manufacturing engineering experience with robotic weld programming, weld parameter development, CAD/CAM proficiency, sheet metal process knowledge, lean improvement experience, and ability to read GD&T and engineering drawings.
Standard Iron: Manufactures custom metal components and assemblies for industrial equipment.
3+ YOE3+ years manufacturing engineering experience with robotic weld programming, weld process development, CAD/CAM proficiency, robot offline/pendant programming, and knowledge of sheet metal processes and lean manufacturing.