Job Summary: Nova Biomedical is seeking a
Manufacturing Mechanical Engineer II to provide technical floor support to reagent, sensor, and tubing manufacturing operations in Waltham, MA. This role will help ensure the on-time delivery of high-quality products at an acceptable cost by investigating manufacturing issues, supporting process and product improvements, and transferring new products and processes into manufacturing.
The Manufacturing Mechanical Engineer II will also contribute to investigations involving in-process and field-returned products to support continuous improvement. Although this position does not have formal direct reports, the individual may provide mentoring and informal oversight to co-op students and interns.
Responsibilities: - Provide day-to-day technical floor support to consumable manufacturing operations by investigating and resolving issues that arise during product manufacturing and processing.
- Test consumables, including sensors, tubing, calibrators, and controls, for functionality using analyzers and production test platforms.
- Measure and inspect components for form, fit, and function and support the disposition of nonconforming products.
- Prepare Manufacturing Variances to document deviations and coordinate the required review and approval process.
- Create and update manufacturing documentation, including Assembly Procedures, Test Procedures, Operating Instructions, Operating Procedures, drawings, and artwork, in compliance with Quality System Regulations and ISO standards.
- Write and/or execute Installation Qualifications, Operational Qualifications, Performance Qualifications, validations, Design of Experiments, Process Failure Mode and Effects Analyses, Process Validation Master Plans, and continuous improvement studies or evaluations.
- Research, specify, and procure equipment for new and existing manufacturing processes and assemblies.
- Design and construct tooling and fixtures for manufacturing processes.
- Modify existing production equipment as needed to improve manufacturing performance.
- Assist with the transfer of new products and processes into manufacturing.
- Collaborate with Research and Development and other manufacturing engineers to develop methods and processes that support production scalability.
- Train assemblers and operators on new processes, assemblies, equipment, tooling, and production methods.
- Contribute to continuous improvement initiatives designed to reduce product costs and cycle times.
- Evaluate and implement lean manufacturing techniques.
- Collaborate with Manufacturing, Research and Development, Quality Assurance, Quality Control, Marketing, Accounting, Purchasing, Planning, and Distribution.
- Mentor and provide informal guidance to co-op students and interns as needed.
Experience Requirements: - Bachelor of Science degree in Mechanical Engineering or Manufacturing Engineering required.
- 3+ of relevant engineering experience desired.
- Advanced proficiency with Microsoft Office, Minitab, SAP, and MasterControl.
- Basic proficiency with SolidWorks.
- Knowledge of FDA Quality System Regulations and ISO standards.
- Experience providing hands-on technical support within a manufacturing environment.
- Experience investigating and resolving manufacturing or product-processing issues.
- Experience testing consumables, components, or products using analyzers or production test platforms.
- Ability to measure and inspect components for form, fit, and function.
- Experience creating or updating regulated manufacturing documentation.
- Experience supporting qualification and validation activities, including IQ, OQ, PQ, DOE, and PFMEA.
- Ability to research, specify, and procure equipment for manufacturing processes.
- Experience designing tooling and fixtures or modifying production equipment.
- Experience supporting new product or process transfers into manufacturing.
- Understanding of lean manufacturing and continuous improvement practices.
- Strong interpersonal and communication skills.
- Strong time-management and risk-management skills.
- Ability to collaborate effectively with technical, manufacturing, quality, and business teams.
- Ability to work independently while contributing effectively within a cross-functional environment.
- Ability to mentor co-op students or interns informally as needed.
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.
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