Manufacturing Mechanical Engineer II

Nova Biomedical • Waltham, MA

5d • Onsite

About The Position

Nova Biomedical is seeking a Manufacturing Mechanical Engineer II to support consumable manufacturing operations at its Waltham, Massachusetts facility, including reagent, sensor, and tubing processes. The engineer independently resolves moderately complex production issues, implements process and equipment improvements, supports product and process transfers, and executes validation and change-control activities. The role collaborates across functions to improve safety, quality, delivery, process capability, and manufacturing cost while maintaining compliance with applicable quality and regulatory requirements. Off-shift technical support and troubleshooting may be needed.

The position provides day-to-day engineering support, leads or supports structured troubleshooting and root-cause investigations, and plans and executes engineering projects. It represents Manufacturing Engineering on cross-functional teams and coordinates implementation with Manufacturing, Quality, Research and Development, Supply Chain, Operations, and suppliers. The engineer prepares and revises controlled manufacturing and engineering documentation, supports equipment and process qualification, and develops tooling, fixtures, process aids, and equipment improvements.

The role also supports new-product introductions, pilot builds, process transfers, manufacturing validations, and continuous-improvement projects. It uses data analysis, Lean methods, Six Sigma tools, and structured problem-solving to improve yield, scrap, cycle time, equipment uptime, labor utilization, and process capability.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• Three or more 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.
• Experience with controlled documentation, technical investigations, change control, and validation practices within a regulated manufacturing environment.
• Experience developing and executing Installation Qualification, Operational Qualification, and Performance Qualification protocols.
• Experience analyzing technical data, documenting deviations, and preparing engineering or validation reports.
• Experience developing tooling, fixtures, process aids, or equipment improvements.
• Experience supporting new-product introductions, pilot builds, process transfers, and manufacturing validations.
• Experience applying structured problem-solving methods to manufacturing and equipment issues.
• Strong interpersonal and communication skills.
• Strong time-management and risk-management skills.
• Ability to independently manage engineering projects and complete deliverables within established scope, quality, cost, and timeline requirements.
• Ability to collaborate effectively with Manufacturing, Quality, Research and Development, Supply Chain, Operations, and external suppliers.
• Able to stand, walk, and move for extended periods.
• Capacity to lift and carry up to 25–50 pounds as required.
• Comfort performing repetitive physical tasks.
• Able to bend, reach, stoop, or climb as needed.
• Willingness to work in varying environmental conditions, such as noise, temperature, and equipment.
• Proficiency in operating tools, machinery, or technical equipment.
• Use of appropriate personal protective equipment is required.

Nice To Haves

• Experience with Minitab, SAP, and MasterControl.
• Medical device manufacturing experience.
• Familiarity with FDA quality-system requirements and ISO 13485 and ISO 9001.
• Six Sigma Yellow Belt certification.

Responsibilities

• Provide day-to-day engineering support for consumable manufacturing processes, equipment, and products.
• Investigate and resolve production 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; analyze product and process data, identify contributing causes, implement corrective actions, and verify effectiveness.
• Plan and execute engineering projects, including establishing tasks and schedules, coordinating resources, monitoring progress, communicating risks, and completing deliverables within approved requirements.
• Represent Manufacturing Engineering on cross-functional teams, provide technical input, complete deliverables, and coordinate implementation with internal functions and suppliers.
• Prepare and revise manufacturing and engineering documentation, including manufacturing variances, engineering change orders, validation protocols and reports, standard operating procedures, work instructions, and engineering drawings.
• Ensure documentation complies with applicable document-control and quality-system requirements.
• Support process and equipment qualification by developing and executing approved Installation Qualification, Operational Qualification, and Performance Qualification protocols; analyze results, document deviations, and prepare technical reports.
• Use engineering studies, Design of Experiments, risk assessments, and Process Failure Mode and Effects Analysis outputs to establish and justify process requirements when 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 manufacturing transfer.
• Support new-product introduction and process-transfer activities by developing manufacturing methods, identifying equipment and tooling requirements, assessing risks, preparing production documentation, supporting pilot builds, and completing transfer and validation deliverables.
• Lead assigned continuous-improvement projects using data analysis, Lean methods, Six Sigma tools, and structured problem-solving.
• Improve manufacturing yield, scrap, cycle time, equipment uptime, labor utilization, and process capability.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at its Norwood, Massachusetts; Billerica, Massachusetts; and Westbrook, Maine offices.
• Company-subsidized cafeteria at its Waltham, Massachusetts office.

What This Job Offers

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