Manufacturing Mechanical Engineer III

Nova Biomedical Corporation • Waltham, MA

1d • Hybrid

About The Position

The Consumable Manufacturing Engineer will provide technical floor support to the reagent, sensor, and tubing manufacturing operations to ensure on-time shipments of high quality products at an acceptable cost. The person will work on process/product improvements and transfer of new products/processes into the manufacturing operations. The individual will also contribute to the investigation of technical issues with in-process or field returned product to ensure continuous improvement. If you’re passionate about manufacturing operations and want to be part of a team that is shaping the future of life sciences, we’d love to hear from you, apply today!

Requirements

• Strong interpersonal and communication skills
• Time and risk management skills
• FDA QSR’s and ISO regulations knowledge

Responsibilities

• Provide day-to-day technical floor support to consumable operations by investigating and resolving issues which arise during the manufacturing/processing of products.
• Test consumables (Sensors, Tubing, Calibrators and Controls) for functionality on analyzers and/or various production test platforms.
• Measure/inspect components for form, fit, and function and disposition nonconforming product.
• Write MVs to document variances and circulate them for signatures.
• Update/create all forms of manufacturing documentation (AP, TP, OI, OP, Drawings and Artwork) which conform to Quality System Regulations (QSR’s) and ISO standards.
• Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Validation Master Plans and Continuous Improvement Studies/Evaluations.
• Research, specify, and procure new equipment for existing or new processes/assemblies.
• Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
• Assist with the transfer of new products to manufacturing.
• Collaborate with R&D and other manufacturing engineers to develop methods/processes to scale production.
• Train assemblers and operators regarding new processes and assemblies.
• Contribute to continuous improvement programs to reduce cost and cycle times of products.
• Examine and implement lean manufacturing techniques.

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program
• Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 251-500 employees