Senior Process Engineer
1 month ago
Responsibilities - Senior Process Engineer
- Lead the research, development, design, and evaluation of mechanical materials, components, assemblies, and processes.
- Conduct in-depth feasibility studies to verify the capability and functionality of new designs and processes, ensuring they meet the highest standards.
- Apply your technical expertise to innovate, design, and develop new processes, procedures, tooling, and automation that enhance manufacturing capabilities.
- Review and coordinate vendor activities, ensuring seamless integration and support for development projects.
- Utilize your expertise in machine design principles and CAD modeling (such as SolidWorks) to
- Design and execute structured experimental plans that drive data-based decisions, leading to product and process improvements.
- Work closely with subject matter experts (SMEs) and R&D teams to develop product concepts, influence design specifications, and provide valuable Design for Manufacturability (DFM) input.
- Develop and own critical processes for complex devices in a pilot environment, ensuring robust and capable operations.
- Tackle complex technical challenges in a hands-on manner, contributing to a fast-paced, innovative work environment.
- Provide structured leadership and problem-solving to drive product and process innovation, guiding the team through strategic process development cycles.
- Contribute ideas or generate Intellectual Property submissions that protect and enhance our technological advancements.
- Assess process capabilities, prioritize improvement opportunities, and implement innovative solutions for platform and derivative projects.
- Execute functional deliverables associated with Product Development Process (PDP)/Technology Development Process (TDP), Project Management, and Quality Systems, ensuring successful project outcomes.
- Organize, and conduct all aspects of technical reviews, providing clear communication and updates to stakeholders.
- Thrive in situations with a high level of ambiguity, working independently to tackle non-routine challenges and deliver results.
- Provide direction and mentorship to technicians and entry-level engineers, fostering a collaborative and innovative team environment.
- 8+ years of relevant work experience in the medical devices manufacturing industry in process engineering
- Strong knowledge of manufacturing processes, materials, and techniques.
- Expertise in process development, with a strong focus on equipment validation, process characterization, and overall validation processes.
- Demonstrated ability to develop processes, fixtures and equipment from concept to production
- Strong mechanical aptitude. Fixture and equipment design or trouble shooting experience.
- Expertise in automating systems, integrating equipment, and developing vision systems, with strong knowledge of advanced automation technologies.
- Hands-on experience with plastics, metals, and various joining methods, demonstrating a broad range of material expertise.
- Degree in Engineering or related Engineering field.
- Proficiency in CAD software and simulation tools (ideally SolidWorks)
- Excellent organizational, communication, and collaboration skills
If you have the experience as a Senior Process Engineer of specialized medical devices, please send your resume today as directed here. While we respect all interested candidates, only profiles meeting the qualifications will be contacted for further discussion. Thank you.
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