Job Title: Manufacturing Engineer

Job Description

Execute plans for major process-related segments of complex product development projects. Compile and analyze process performance data to establish process design and specifications for newly designed or modified products. Plan and validate equipment and processes of newly designed products to internal and external requirements. Execute process development-related activities on projects.

Responsibilities

• Lead the design, development, characterization, and validation of manufacturing processes for new product development.
• Plan, organize, and coordinate technical activities to transition products from concept to final realization.
• Execute key deliverables to advance processes from feasibility through production launch.
• Advocate for Design for Manufacturability (DFM) during early development phases to ensure robust and scalable product designs.
• Identify and implement suitable manufacturing processes and equipment to optimize product manufacturability.
• Oversee the manufacturing processes of both new and existing products, ensuring efficiency, scalability, and quality.
• Develop innovative solutions to complex engineering challenges by revising standard technical principles and methodologies.
• Prepare project plans, specifications, resource allocations, and schedules for new product development initiatives.
• Collaborate with engineers, technicians, contract manufacturers, and assemblers to support prototype manufacturing, process development, and validation activities.
• Define critical process parameters and develop comprehensive validation plans, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and external service validations.
• Define and track key process performance metrics (yield, capacity, capability, efficiency) to ensure successful production transfer.
• Establish and optimize new and existing processes to meet product design and performance criteria.
• Conduct troubleshooting, validation, and continuous process improvements to enhance efficiency and product quality.
• Collaborate with internal and external vendors to design tooling and fixtures for manufacturing.
• Develop and implement Control Plans to ensure process consistency and compliance.

Essential Skills

• 5+ years of experience in manufacturing and process development within a regulated environment.
• Strong knowledge in equipment and floor support.
• Experience in catheter product work history, process development, development, manufacturing engineering, R&D, vendor management, test method, continuous improvement, process engineering, process improvement, and lean manufacturing.

Additional Skills & Qualifications

• Experience with product development engineering, device manufacturing, and process development.

Work Environment

The work environment is very relaxed with a family-first mindset. Everyone feels part of the team and there are various structured activities like team lunches, outings, happy hours, and events. The company also offers some flexibility for working from home depending on workload and role. There is a strong emphasis on work/life balance. The facility includes a golf simulator, a full-scale gym, a sauna, and locker rooms.