Manufacturing Mechanical Engineer II

NOVA Biomedical GmbH; Waltham (MA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

401k match

Bonus program

PTO & holidays

Hybrid work arrangements

Job summary

Nova Biomedical Corporation seeks a Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA, ensuring on-time delivery of high‑quality products at acceptable cost by troubleshooting issues and supporting process improvements.

This position also contributes to investigations of in‑process and field‑returned products, mentors co‑ops and interns informally, and collaborates with R&D and other manufacturing

Qualifications

• BS degree in Mechanical or Manufacturing Engineering required.
• 3+ years of relevant engineering experience preferred.
• Proficiency with SAP, MasterControl, and MS Office.
• Basic proficiency with SolidWorks.
• Knowledge of FDA QSR and ISO standards.
• Experience in manufacturing environment and process validation.

Responsibilities

• Provide day-to-day technical floor support to consumable manufacturing operations by investigating and resolving issues that arise during product manufacturing and processing.
• Test consumables, including sensors, tubing, calibrators, and controls, for functionality using analyzers and production test platforms.
• Measure and inspect components for form, fit, and function and support the disposition of nonconforming products.
• Prepare Manufacturing Variances to document deviations and coordinate the required review and approval process.
• Create and update manufacturing documentation, including Assembly Procedures, Test Procedures, Operating Instructions, Operating Procedures, drawings, and artwork, in compliance with Quality System Regulations and ISO standards.
• Write and/or execute Installation Qualifications, Operational Qualifications, Performance Qualifications, validations, Design of Experiments, Process Failure Mode and Effects Analyses, Process Validation Master Plans, and continuous improvement studies or evaluations.
• Research, specify, and procure equipment for new and existing manufacturing processes and assemblies.
• Design and construct tooling and fixtures for manufacturing processes.
• Modify existing production equipment as needed to improve manufacturing performance.
• Assist with the transfer of new products and processes into manufacturing.
• Collaborate with Research and Development and other manufacturing engineers to develop methods and processes that support production scalability.
• Train assemblers and operators on new processes, assemblies, equipment, tooling, and production methods.
• Contribute to continuous improvement initiatives designed to reduce product costs and cycle times.
• Evaluate and implement lean manufacturing techniques.
• Collaborate with Manufacturing, Research and Development, Quality Assurance, Quality Control, Marketing, Accounting, Purchasing, Planning, and Distribution.
• Mentor and provide informal guidance to co‑op students and interns as needed.

Skills

MS Office

Minitab

Strong communication

Cross-functional collaboration

Engineering problem-solving

Education

Bachelor of Science in Mechanical Engineering

Tools

SAP

MasterControl

SolidWorks

Job description

Career Opportunities with Nova Biomedical Corporation

Nova Biomedical is an Equal Opportunity Employer in compliance with affirmative action in hiring and promoting women, minorities, veterans and individuals with disabilities.

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.

Job Summary:

Nova Biomedical is seeking a Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA. This role will help ensure the on‑time delivery of high‑quality products at an acceptable cost by investigating manufacturing issues, supporting process and product improvements, and transferring new products and processes into manufacturing.

The Manufacturing Mechanical Engineer II will also contribute to investigations involving in‑process and field‑returned products to support continuous improvement. Although this position does not have formal direct reports, the individual may provide mentoring and informal oversight to co‑op students and interns.

Responsibilities:

• Provide day‑to‑day technical floor support to consumable manufacturing operations by investigating and resolving issues that arise during product manufacturing and processing.
• Test consumables, including sensors, tubing, calibrators, and controls, for functionality using analyzers and production test platforms.
• Measure and inspect components for form, fit, and function and support the disposition of nonconforming products.
• Prepare Manufacturing Variances to document deviations and coordinate the required review and approval process.
• Create and update manufacturing documentation, including Assembly Procedures, Test Procedures, Operating Instructions, Operating Procedures, drawings, and artwork, in compliance with Quality System Regulations and ISO standards.
• Write and/or execute Installation Qualifications, Operational Qualifications, Performance Qualifications, validations, Design of Experiments, Process Failure Mode and Effects Analyses, Process Validation Master Plans, and continuous improvement studies or evaluations.
• Research, specify, and procure equipment for new and existing manufacturing processes and assemblies.
• Design and construct tooling and fixtures for manufacturing processes.
• Modify existing production equipment as needed to improve manufacturing performance.
• Assist with the transfer of new products and processes into manufacturing.
• Collaborate with Research and Development and other manufacturing engineers to develop methods and processes that support production scalability.
• Train assemblers and operators on new processes, assemblies, equipment, tooling, and production methods.
• Contribute to continuous improvement initiatives designed to reduce product costs and cycle times.
• Evaluate and implement lean manufacturing techniques.
• Collaborate with Manufacturing, Research and Development, Quality Assurance, Quality Control, Marketing, Accounting, Purchasing, Planning, and Distribution.
• Mentor and provide informal guidance to co‑op students and interns as needed.

Experience Requirements:

• Bachelor of Science degree in Mechanical Engineering or Manufacturing Engineering required.
• 3+ of relevant engineering experience desired.
• Advanced proficiency with Microsoft Office, Minitab, SAP, and MasterControl.
• Basic proficiency with SolidWorks.
• Knowledge of FDA Quality System Regulations and ISO standards.
• Experience providing hands‑on technical support within a manufacturing environment.
• Experience investigating and resolving manufacturing or product‑processing issues.
• Experience testing consumables, components, or products using analyzers or production test platforms.
• Ability to measure and inspect components for form, fit, and function.
• Experience creating or updating regulated manufacturing documentation.
• Experience supporting qualification and validation activities, including IQ, OQ, PQ, DOE, and PFMEA.
• Ability to research, specify, and procure equipment for manufacturing processes.
• Experience designing tooling and fixtures or modifying production equipment.
• Experience supporting new product or process transfers into manufacturing.
• Understanding of lean manufacturing and continuous improvement practices.
• Strong interpersonal and communication skills.
• Strong time‑management and risk‑management skills.
• Ability to collaborate effectively with technical, manufacturing, quality, and business teams.
• Ability to work independently while contributing effectively within a cross‑functional environment.
• Ability to mentor co‑op students or interns informally as needed.

Physical Requirements and Working Conditions:

• Able to stand, walk, and move for extended periods.
• Capacity to lift and carry up to [25–50] pounds as required.
• Comfort with performing repetitive physical tasks.
• Able to bend, reach, stoop, or climb as needed.
• Willingness to work in varying environmental conditions (e.g., noise, temperature, equipment).
• Proficiency in operating tools, machinery, or technical equipment.
• Use of appropriate personal protective equipment (PPE) required.

Why Work for Nova Biomedical

• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Hybrid and flexible work arrangements
• Professional development, engagement and events

  Work Location:

  Onsite in Waltham, MA

  Targeted Salary Range:

  $90,000 to $105,000 yearly

  Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

  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.

  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.