Job Description:
The Sustaining Engineer collaborates with R&D, Operations, Process Engineering, Quality, and Customer Service to improve products and processes.
Responsibilities:
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Project Management: Oversee commercialization and enhancements for new products, including validation, optimization, and cost reduction.
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Problem-Solving: Address product and manufacturing issues, both internal and external.
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Supplier Quality: Support sourcing and ensure supplier quality.
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Change Management: Facilitate product and process change management.
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Capital Equipment: Specify and qualify capital equipment.
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Documentation: Author and update technical and process documentation.
Essential Functions:
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Technical Expertise: Provide technical support to other functional areas.
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Mechanical Design Analysis: Analyze designs and measurement systems.
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Product Testing: Conduct product verification and validation testing.
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Design Integration: Integrate Design for Manufacture & Assembly and Design to Cost perspectives.
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Process Studies: Lead yield improvements, reduce variability, and support manufacturing.
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Root Cause Analysis: Resolve product issues and implement design enhancements.
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Customer Complaints: Investigate complaints, propose design changes, and monitor effectiveness.
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Compliance: Support audits, resolve CAPAs and NCRs, and ensure product compliance.
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Supplier Redundancy: Create supplier redundancy and reduce costs.
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Collaboration: Interact with key personnel and external partners.
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Relationship Building: Maintain positive working relationships across the organization.
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Additional Duties: Perform other duties as assigned.
Qualifications:
- Bachelor's degree in Engineering; Master's preferred.
- 8+ years of experience in plastic design and manufacturing.
- Expertise in design verification, process validation, and report writing.
- Proficiency in design control, change control, and risk management.
- Ability to innovate and solve problems.
- Strong project management and organizational skills.
- Effective communication and interpersonal skills.
- Experience in GMP or laboratory environments.
- Willingness to travel up to 10%.
Preferred Experience:
- Single Use Consumable design and development.
- Process characterization and optimization.
- Statistical Process Control (SPC) experience.