Manufacturing Engineer II

Nova Biomedical • Waltham, MA

16d • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• 3+ years of experience in manufacturing, mechanical, process, or a related engineering field.
• Proficiency with standard Microsoft Office applications.
• Experience using statistical analysis, enterprise resource planning, and electronic document control systems.
• 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.

Nice To Haves

• Experience with Minitab, SAP, and MasterControl.
• Experience in medical device manufacturing and familiarity with FDA quality system requirements and ISO 13485 and 9001.
• Six Sigma Yellow Belt certification.

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, including off-shift technical support and troubleshooting when needed.
• Lead or support structured troubleshooting and root-cause investigations; analyze process and product data, identify causes, implement corrective actions, and verify effectiveness.
• Plan and execute assigned engineering projects, including establishing tasks and schedules, coordinating resources, monitoring progress, communicating risks, and completing deliverables within approved scope, quality, cost, and timeline requirements.
• Represent Manufacturing Engineering on assigned cross-functional teams 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.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) 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 at the Norwood, MA; Billerica, MA; and Westbrook, ME offices.
• Company-subsidized cafeteria at the Waltham, MA office.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level