Manufacturing Engineer II

Career Opportunities with Nova Biomedical Corporation Nova Biomedical is an Equal Opportunity Employer in compliance with affirmative action in hiring and promoting women, minorities, veterans and individuals with disabilities. Job Summary The Manufacturing Engineer will provide technical support for all Point of Care meter manufacturing operations under the direction of the Sr Manager and Technical Leads. This role will contribute to the development, design and validation of existing and new equipment or processes. Responsible for updating or writing the support documentation (Dwgs, BOMS, Assembly/Test Procedures, Operating Procedures or Instructions) for all POC products. Responsible for participating in development, writing and performing IQ, OQ, PQ and VQ’s for all POC products along with support equipment/processes. Assist and/or perform engineering studies to problem-solve, improve process reliability, or to improve product quality and/or cost. Be an active participant within the manufacturing team to drive departmental and company success. Responsibilities Update/create all forms of manufacturing documentation (AP/TP/OI/OP/BOM/DWG/Artwork) which conform to Quality System Regulations (QSR’s) and ISO Standards. Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Master Validation Plans and Continuous Improvement studies/evaluations. Provide day to day technical floor support by investigation and resolution of issues that arise during the manufacturing process. Assist with transfer of new products to manufacturing. Collaborate with R&D and others to develop production processes, tools, and equipment. Train assemblers and operators regarding new processes and assemblies. Contribute to continuous improvement programs to reduce cost, cycle times and increase quality. Experience Requirements Proficiency in Microsoft Office & Solidworks Experience with Business Operating Systems such as SAP B.S. in Mechanical, Electrical, or Industrial Engineering Strong communication and interpersonal skills Hands On approach to problem solving An understanding of FDA QSR’s and ISO regulations. Physical Requirements and Working Conditions Being able to sit/stand for extended periods of time Being able to traverse the manufacturing floor Being able to lift 20 lbs. Benefits Competitive 401k company match Bonus Program, Generous PTO and paid holidays 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: Hybrid in our Billerica, Lexington Rd Facility Targeted Salary Range: $100,000 - $110,000/year Working Hours: 7:30am to 4:00pm #J-18808-Ljbffr