Senior Process Engineer
1 week ago
Job Title: Senior Process Engineer - Medical Devices
Job Summary:
We are seeking a highly skilled Senior Process Engineer to join our team in the medical devices industry. As a key member of our process development team, you will be responsible for leading the research, development, design, and evaluation of mechanical materials, components, assemblies, and processes.
Key Responsibilities:
- 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.
- 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.
- 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.
Qualifications:
- 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
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