The Senior Engineer coordinates with partners to deliver business value through solution execution, ensures product quality, and leads process reviews and validations.
Work Flexibility: Hybrid
What you will do:
Key responsibilities:
- Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
Who we want:
Minimum Requirements:
- Bachelor’s degree (B.E.) in Mechanical or related engineering discipline required.
- 5+ years of work experience required
- Analytical problem solvers
- Dedicated achievers
- Collaborative partners
Preferred Qualifications:
- Good knowledge of manufacturing processes, materials, product, and process design
- Project Management experience
- Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or ISO 13485 regulated industry- highly preferred.
- Good understanding of Design for Manufacturing (DFM) related statistical tools and validation/verification technique
Travel Percentage: None
Top Skills
Design For Manufacturing (Dfm)
Fda Regulations
Iso Standards
Mechanical Engineering
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