Manufacturing; Mechanical Engineer III

Manufacturing (Mechanical) Engineer III Department:
Mfg. Eng.

- Consumables

Location:

Waltham, MA

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Nova Biomedical:
One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

About the company

At Nova Biomedical, were not just building instruments, were powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Novas cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, were setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, were building a collaborative, empowered culture grounded in shared values:
Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, youll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

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About the role

As the Consumable Manufacturing Engineer, you will provide technical floor support to 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.

If youre passionate about manufacturing operations and want to be part of a team that is shaping the future of life sciences, wed love to hear from you, apply today!

What youll do

* 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 (QSRs) 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.

What we are looking for in you

* 5+ years of experience in manufacturing or process engineering

* Proficiency in Solid Works, Minitab, SAP, Master Control, and Microsoft Office

* Strong Solidworks 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 QSRs and ISO regulations knowledge

Physical Requirements for this role include:

Ability to stand, walk, and move for extended periods.

Ability to lift and carry up to [2550] pounds as required.

Ability to perform repetitive physical tasks.

Ability to bend, reach, stoop, or climb as needed.

Ability to work in varying environmental conditions (e.g., noise, temperature, equipment).

Ability to…