Job Summary: Nova Biomedical is seeking a
Manufacturing Mechanical Engineer II to support consumable manufacturing operations at our Waltham, MA facility, including reagent, sensor, and tubing processes. This role will independently resolve production issues of moderate complexity, implement process and equipment improvements, support product and process transfers, and execute validation and change-control activities.
The Manufacturing Engineer II will collaborate across functions to improve safety, quality, delivery, process capability, and manufacturing cost while maintaining compliance with applicable quality and regulatory requirements. This position may also provide off-shift technical support and troubleshooting when needed to support manufacturing operations
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.
- Define technical problems, analyze product and process data, identify contributing causes, implement corrective actions, and verify their effectiveness.
- Plan and execute assigned engineering projects.
- Establish project 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, Research and Development, Supply Chain, Operations, and suppliers.
- Prepare and revise manufacturing and engineering documentation, including:
- Manufacturing variances
- Engineering change orders
- Validation protocols and reports
- Standard operating procedures
- Work instructions
- 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 qualification 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 technical requirements, prepare design documentation, assess risks, and support testing, qualification, change control, and transfer to manufacturing.
- Support new-product introduction and process-transfer activities.
- Develop manufacturing methods and identify equipment and tooling requirements.
- Assess process risks, prepare production documentation, support pilot builds, and complete assigned 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.
Experience Requirements: - Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline required.
- Three or more years of experience in manufacturing, mechanical, process, or a related engineering field required.
- Proficiency with standard Microsoft Office applications.
- Experience using statistical-analysis, enterprise-resource-planning, and electronic document-control systems.
- Experience with Minitab, SAP, and MasterControl preferred.
- Proficiency with SolidWorks, including the ability to independently develop and revise 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.
- Medical device manufacturing experience preferred.
- Familiarity with FDA quality-system requirements and ISO 13485 and 9001 preferred.
- Six Sigma Yellow Belt certification preferred.
Physical Requirements and Working Conditions: - Able to stand, walk, and move for extended periods.
- Capacity to lift and carry up to [25-50] pounds as required.
- Comfort with performing repetitive physical tasks.
- Able to bend, reach, stoop, or climb as needed.
- Willingness to work in varying environmental conditions (e.g., noise, temperature, equipment).
- Proficiency in operating tools, machinery, or technical equipment.
- Use of appropriate personal protective equipment (PPE) required.
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 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: Onsite in Waltham, MA
Targeted Salary Range: $90,000 to $105,000 yearly
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.
