Production Engineer

Whitridge Associates • billerica, ma, us • 4w ago

Essential Responsibilities:

Production Support: Collaborate with production operators and R&D engineers to identify and prioritize process improvement initiatives aimed at enhancing yield, reducing costs, and maximizing ROI. Lead the implementation of these improvements on the production floor.
Fixture and Equipment Design: Design or source new fixtures and equipment as needed, including overseeing documentation, qualification, validation, and maintenance processes.
Process Documentation: Develop and maintain comprehensive process documentation, including assembly and test procedures, equipment and component specifications, BOMs, process flows, and FMEAs.
Failure Investigation: Participate in the investigation of failures and develop actionable plans for corrective actions in response to audits and findings. Address work-in-progress (WIP) and incoming Material Review Board (MRB) issues promptly.
Supplier Coordination: Manage fabrication and procurement activities with external suppliers to ensure timely delivery of materials and equipment.
Regulatory Compliance: Support and uphold company objectives, policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), as well as FDA Quality System Regulations (QSR) and ISO standards. Knowledge of FDA QSR and ISO regulations is essential.
Cross-Functional Collaboration: Work effectively within a cross-functional team in a startup environment. Strong communication skills are required to convey technical updates and issues, with a preference for collaborative efforts over individual contributions.
Project Reporting: Provide regular updates on project status and schedule, utilizing key project metrics in presentations, action items, and meeting minutes for program and operations management.
Documentation Maintenance: Ensure accurate documentation of concepts, designs, and processes, while keeping abreast of advancements in medical, technical, and biomedical fields relevant to products.
Product Development Collaboration: Partner with product development teams to ensure that products are designed with manufacturability, testing, and inspection considerations in mind.

Related Jobs

Principal Systems Engineer

Raytheon • tewksbury, ma, us • 10h ago

10h ago

UPS - Package Delivery Driver $16-$35/hr

Apptness.io • malden, ma, us • 10h ago

10h ago

Travel CT Technologist - $3,140 per week

LRS Healthcare - Imaging • winchester, ma, us • 10h ago

10h ago

Certified Registered Nurse Anesthetist (CRNA)

Curative • burlington, ma, us • 10h ago

10h ago

Logistics Coordinator

Abacus Solutions Group • wakefield, ma, us • 10h ago

10h ago

Warehouse Person (Full Time/Part Time Loader) - PepsiCo $16-$35/hr

Apptness.io • lowell, ma, us • 10h ago

10h ago

Home Health LPN-Lowell

Tufts Medicine Care at Home • lowell, ma, us • 10h ago

10h ago

Whole Foods Team Member (Flexible Full & Part Time Storewide Roles)

Whole Foods • westford, ma, us • 10h ago

10h ago

Coca-Cola Sales Merchandiser $16-$35/hr

Apptness.io • medford, ma, us • 10h ago

10h ago

LPN Home Health Full Time

CenterWell Home Health • wayland, ma, us • 10h ago

10h ago