Manufacturing Engineer II

NOVA Biomedical GmbH; Waltham, Northern (MA, KY); Hybrid; USD 90,000 - 105,000; Full time

Benefits offered by this job

401k match

Bonus program

Generous PTO

Hybrid work

Professional development

Office cafeteria

Job summary

Nova Biomedical seeks a Manufacturing Engineer II to support consumable manufacturing—reagent, sensor, and tubing processes. The role resolves production issues, implements improvements, and supports transfers with cross‑functional teams to enhance safety, quality, delivery, and cost.

The ideal candidate has a mechanical/manufacturing engineering degree and 3+ years in manufacturing, with experience in documentation, validation, and risk management. Hybrid work available; salary range $90k–$105k.

Qualifications

• Bachelor’s degree in Mechanical or Manufacturing Engineering is required.
• 3+ years of manufacturing/engineering experience.
• Experience with validated documentation, change control, and compliance processes.
• Familiarity with FDA QSR and ISO 13485 preferred.
• Six Sigma Yellow Belt preferred.

Responsibilities

• Provide day-to-day engineering support for consumable manufacturing processes and equipment.
• Lead or support root-cause investigations and implement corrective actions.
• Plan and execute engineering projects with defined scope, schedule, and budget.
• Represent Manufacturing Engineering on cross-functional teams and coordinate with QA/R&D/Supply Chain.
• Prepare and revise manufacturing documentation including SOPs, change orders, and validation reports.
• Support IQ/OQ/PQ protocols; analyze results and document deviations.
• Develop tooling, fixtures, and process aids; document designs and risks.
• Support new-product introduction and process transfer, including pilot builds.
• Lead continuous-improvement projects using Lean and Six Sigma methods to improve yield and cycle time.
• Perform other duties as assigned.

Skills

Root cause analysis

Lean methods

Six Sigma

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Mechanical/Manufacturing Engineering

Tools

SolidWorks

Minitab

SAP

MasterControl

Excel

Job description

Nova Biomedical is an Equal Opportunity Employer in compliance with …

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:

The Manufacturing Engineer II provides manufacturing engineering support for Nova Biomedical’s consumable manufacturing operations, including reagent, sensor, and tubing processes. The role independently resolves production issues of moderate complexity, implements process and equipment improvements, supports product and process transfers, and executes validation and change-control activities. The engineer works cross-functionally to improve safety, quality, delivery, process capability, and manufacturing cost while maintaining compliance with applicable quality and regulatory requirements.

Responsibilities:

• Provide day-to-day engineering support for consumable manufacturing processes, equipment, and products. Investigate and resolve issues affecting safety, quality, throughput, cost, or delivery. Provide off-shift technical support and troubleshooting when needed to support manufacturing operations.
• Lead or support structured troubleshooting and root-cause investigations. Define the problem, analyze process and product data, identify contributing causes, implement corrective actions, and verify their effectiveness.
• Plan and execute assigned engineering projects. Establish tasks and schedules, coordinate resources, monitor progress, identify and communicate risks, and complete deliverables within approved scope, quality, cost, and timeline requirements.
• Represent Manufacturing Engineering on assigned cross-functional teams. Provide technical input, complete assigned deliverables, and coordinate implementation with Manufacturing, Quality, R&D, Supply Chain, Operations, and suppliers.
• Prepare and revise manufacturing and engineering documentation, including manufacturing variances, engineering change orders, validation protocols and reports, SOPs, work instructions, and drawings, in accordance with document-control and quality-system requirements.
• Support process and equipment qualification by developing and executing approved IQ, OQ, and PQ protocols; analyzing results; documenting deviations; and preparing reports. Use engineering studies, DOE, risk assessments, and PFMEA outputs to establish and justify process requirements, as appropriate.
• Develop and implement tooling, fixtures, process aids, and equipment improvements. Define requirements; prepare design documentation; assess risks; and support testing, qualification, change control, and transfer to manufacturing.
• Support new-product introduction and process transfer by developing manufacturing methods, identifying equipment and tooling needs, assessing process risks, preparing production documentation, supporting pilot builds, and completing assigned transfer and validation deliverables.
• Lead assigned continuous-improvement projects using data analysis, Lean methods, Six Sigma tools, and structured problem-solving to improve yield, scrap, cycle time, equipment uptime, labor utilization, or process capability.
• Perform other duties as assigned.

Experience Requirements:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline is required.
• 3+ years of experience in manufacturing, mechanical, process, or a related engineering field is required.
• Proficiency with standard Microsoft Office applications and experience using statistical analysis, enterprise resource planning, and electronic document control systems. Experience with Minitab, SAP, and MasterControl is preferred.
• Proficiency with SolidWorks, including independently developing and revising tooling, fixture, and component designs and associated drawings.
• Experience supporting manufacturing investigations, process improvements, equipment changes, and nonconforming product reviews.
• Strong interpersonal, communication, time-management, and risk-management skills.
• Experience with controlled documentation, investigations, change control, and validation practices in a regulated manufacturing environment is required. Experience in medical device manufacturing and familiarity with FDA quality system requirements and ISO 13485 are preferred.
• Six Sigma Yellow Belt certification is preferred.

Physical Requirements and Working Conditions:

• Ability to alternate between sitting and standing and perform activities that may include walking, pushing, pulling, bending, kneeling, reaching, twisting, turning, and climbing steps.
• Ability to lift and carry up to 25 pounds periodically during a shift.
• Ability to perform repetitive hand, wrist, and arm movements when operating equipment or using a computer.
• Ability to wear required personal protective equipment, which may include safety glasses, safety shoes, a lab coat, bouffant (including beard if not clean shaven), gloves, hearing protection, a face shield, or a nuisance mask.

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

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: Waltham, MA - Onsite M-F

Targeted Salary Range: $90,000 - 105,000

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.