Instructions for hiring Managers: Use the following template to insert the job-specific content for the role you are requesting. Note: HR will review the posting content and remove any formatting issues (highlights or boxes) before making the post live.
Once all fields are completed, submit the requisition for approval. If you only press save, this will not get submitted properly. 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 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.
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: 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.
function load() { var urllocation = location.href; //find url parameter if(urllocation.indexOf("#") == -1 || urllocation.indexOf("#job") > -1){ window.location.hash="#job"; } }
