Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field required.
3+ years of experience in manufacturing or related engineering field required.
Proficient in Microsoft Office and statistical analysis tools; experience with Minitab, SAP, and MasterControl preferred.
SolidWorks proficiency for developing and revising designs and drawings.
Experience in manufacturing investigations and process improvements required.
Strong interpersonal and communication skills essential.
Familiarity with FDA quality system requirements and ISO standards preferred; Six Sigma Yellow Belt certification is a plus.
Responsibilities
Provide engineering support for consumable manufacturing processes and troubleshoot production issues.
Lead structured troubleshooting and root-cause investigations to implement corrective actions.
Plan and execute engineering projects, coordinating resources and monitoring progress.
Represent Manufacturing Engineering on cross-functional teams, providing technical input and coordinating implementation.
Prepare and revise engineering documentation in compliance with quality-system requirements.
Support process qualification by developing and executing validation protocols and analyzing results.
Develop and implement tooling and equipment improvements, ensuring compliance with design requirements.
Benefits
Comprehensive health insurance plans.
401(k) retirement plan with company match.
Paid time off and holidays.
Opportunities for professional development and training.
Collaborative work environment with a focus on innovation.
Full Job Description
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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 and 9001 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.
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 Nova Biomedical
Nova Biomedical is a privately held medical device company based in Waltham, Massachusetts. The company develops, manufactures, and sells blood testing analyzers, and provides diagnostic testing solutions for hospitals, clinics, and laboratories worldwide. Nova Biomedical's products are used in critical care settings, emergency rooms, physician offices, and clinics. The company's products include point-of-care blood gas and electrolyte analyzers, as well as benchtop laboratory analyzers. Nova Biomedical was founded in 1976 by Robert C. Collins, and is still owned by the Collins family.
