Manufacturing Engineer II

Manufacturing Engineer

The Manufacturing Engineer will provide technical support for all Point of Care meter manufacturing operations under the direction of the Sr Manager and Technical Leads. This role will contribute to the development, design and validation of existing and new equipment or processes. Responsible for updating or writing the support documentation (Dwgs, BOMS, Assembly/Test Procedures, Operating Procedures or Instructions) for all POC products. Responsible for participating in development, writing and performing IQ, OQ, PQ and VQ's for all POC products along with support equipment/processes. Assist and/or perform engineering studies to problem-solve, improve process reliability, or to improve product quality and/or cost. Be an active participant within the manufacturing team to drive departmental and company success.

Responsibilities:

• Update/create all forms of manufacturing documentation (AP/TP/OI/OP/BOM/DWG/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 Master Validation Plans and Continuous Improvement studies/evaluations.
• Provide day to day technical floor support by investigation and resolution of issues that arise during the manufacturing process.
• Assist with transfer of new products to manufacturing. Collaborate with R&D and others to develop production processes, tools, and equipment.
• Train assemblers and operators regarding new processes and assemblies.
• Contribute to continuous improvement programs to reduce cost, cycle times and increase quality.

Experience Requirements:

• Proficiency in Microsoft Office & Solidworks
• Experience with Business Operating Systems such as SAP
• B.S. in Mechanical, Electrical, or Industrial Engineering
• Strong communication and interpersonal skills
• Hands On approach to problem solving
• An understanding of FDA QSR's and ISO regulations.

Physical Requirements and Working Conditions:

• Being able to sit/stand for extended periods of time
• Being able to traverse the manufacturing floor
• Being able to lift 20 lbs.

Why work for Nova Biomedical

• 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

Work Location: Hybrid in our Billerica, Lexington Rd Facility

Targeted Salary Range: $100,000 - $110,000/year

Working Hours; 7:30am to 4:00pm

About the company

At Nova Biomedical, we're not just building instruments, we're 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 Nova's 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, we're 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, we're 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, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.