Manufacturing; Mechanical Engineer III

About The Role

As the Consumable Manufacturing Engineer, you 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. You will work on process/product improvements and transfer of new products/processes into the manufacturing operations. You will also contribute to the investigation of technical issues with in‑process or field returned product to ensure continuous improvement.

• 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.

• 5+ years of experience in manufacturing or process engineering
• Proficiency in Solid Works, Minitab, SAP, Master Control, and Microsoft Office
• Strong Solid Works foundation with the ability to design complex fixtures
• Strong knowledge of Lean manufacturing and continuous improvement methodologies
• Experience with statistical analysis and process validation techniques
• Strong interpersonal and communication skills
• Time and risk management skills
• FDA QSR’s and ISO regulations knowledge

• Must be able to perform tasks that may involve extended periods of time standing, sitting, pushing, pulling, lifting, bending, kneeling, reaching, twisting, turning, climbing steps and carrying up to 25 pounds several times/hours a shift.
• Require repetitive use of arms/wrist/hands while setting up/working with equipment/computer throughout the shift.
• Will require use of Personal Protective Equipment (PPE) and may include, but not limited to, safety glasses, safety shoes, lab coat, bouffant, gloves, hearing protection, face shield, nuisance mask.
• The full list of physical requirements for this role is available upon request.

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401(k) 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

Hybrid work schedule on‑site in Waltham.

$110,000 - $115,000 per year.

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.