Manufacturing Engineer II

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

Benefits offered by this job

Hybrid and flexible work arrangements

Bonus Program, Generous PTO and paid H

Generous Tuition reimbursement

Competitive 401k company match

Job summary

Nova Biomedical in Waltham, MA, is seeking a Manufacturing Engineer II to support consumable manufacturing operations, including reagents, sensors and tubing. You will resolve production issues, implement process improvements, and contribute to validations and change-control activities in a regulated environment.

Responsibilities include troubleshooting, leading projects, drafting manufacturing and engineering documentation, and supporting transfer and new-product introductions.

Qualifications

• Bachelor’s degree in Mechanical/Manufacturing Engineering or related field.

Responsibilities

• Provide day-to-day engineering support for consumable manufacturing processes, equipment, and products.
• Lead or support structured troubleshooting and root-cause investigations.
• Plan and execute assigned engineering projects within scope, time, and budget.
• Represent Manufacturing Engineering on cross-functional teams with Manufacturing, Quality, R&D, and Supply Chain.
• Prepare and revise manufacturing documents and validation reports per quality-system requirements.
• Support IQ/OQ/PQ protocols, DOE, and PFMEA to establish process requirements.
• Develop tooling, fixtures, and process aids; support testing and transfer to manufacturing.
• Lead continuous-improvement projects to improve yield, cycle time, and equipment uptime.

Skills

Manufacturing Engineering

Root Cause Analysis

DOE

Six Sigma

SolidWorks

Minitab

SAP

MasterControl

Change Control

Education

Bachelor's in Mechanical/Manufacturing Engineering

Tools

SolidWorks

Minitab

SAP

MasterControl

Documentation Systems

Job description

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

• 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 eventsCompany 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

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.

Explore what’s next with us at novabiomedical.com

EEO Statement

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.

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https://www.novabiomedical.com/privacy-policy/