Manufacturing Engineer-Medical Device

Role: Manufacturing Engineer

Locations : Prefer in the greater Minneapolis area or in Santa Rosa locals

Role and Responsibilities:

• Collaborate on the project team and work under the direction of the Project Manager in a fast-paced environment supporting program initiatives and compliant with company best practices.
• Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
• Familiar with DHR/DMR/QSR, manufacturing process (drilling, milling, turning, assembly operations, cleaning operations, sterilization, Sealing process, Heat flow process, water resistant process etc.) and procedures.
• Familiar with Safety Data Sheets/Consumables having PFAS.
• Familiar with calibration process, lab testing equipment
• Knowledge about PFAS, PTFE Materials, REACH Regulation
• Inspect the machinery, equipment, and tools, analyse the manufacturing documents (DHR/WI/OP) to understand the indirect component to evaluate the potential impact by PFAS.
• Working knowledge of manual and automated/semi-automated equipment.
• Generate and revise Bills of Materials as applied to versioning.
• Working under the guidance of the Senior and/or Principal Engineer.
• The Manufacturing Engineer must be familiar with IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) documentation and execution.
• Conduct, coordinate, and aid in formal Process Validations including protocol development and execution.
• Knowledge about pre-printed materials and labelling.
• Co-ordination with Supplier quality and/or Material experts and status reporting to Project Manager
• Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.
• Dynamic team player and can work effectively and proactively on cross-functional teams
• Prior experience as FTE engaged on the manufacturing floor (including cleanrooms)
• The employee is also required to interact with a computer, and communicate with peers and co-workers

Must Have:

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have:

• Audit Training (ISO 13485 and FDA 21CFR820 Training)
• Tools:
• AgileMap, CAP Agile, Enovia, Windchill.
• SAP
• SDS database (e.g Demarco, Sphera)
• Minitab
• Maximo
• BPCS
• Past Experience with Medtronic

Job Type: Contract

Salary: $50.00 - $55.00 per hour

Schedule:

• 8 hour shift

Work setting:

• In-person

Work Location: In person