Senior Manufacturing Engineer (NPI)
Are you looking to be part of a game-changing organization that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team in Beloit, WI.
NorthStar develops, manufactures, and distributes radioisotopes used daily for patients needing medically important diagnostic imaging tests. Using novel and advanced technologies, NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader.
Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.
The NPI (New Product Introduction) Manufacturing Engineer is responsible for the successful launch of future NorthStar products. This position will identify, implement, and validate capital equipment, tooling, and manufacturing processes required to successfully launch new products. All duties and responsibilities will be done in compliance with cGMP and FDA regulations.
The NPI Manufacturing Engineer operates cross-functionally between assembly, manufacturing, quality, and product development teams. This includes the estimation of future manufacturing requirements and performs capacity analyses. Analyzes and plans space requirements, workflow; designs layout of equipment and workspace for maximum efficiency. Using Lean Six Sigma or related tools to develop cost-effective solutions and lead successful implementation to deliver improved product quality.
Duties and Responsibilities
- Provides product and process DFx (Manufacturing, Test, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
- Takes ownership of new products during the pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
- Proactively evaluate and challenge designs for technical merit, reliability, serviceability, and manufacturability working with the design team to realize optimal outcomes.
- Creates an assembly line, specifying and/or refining BOMs, detailed work instructions, and Batch Production Records/Device History Records. This includes developing the process flow and Process Failure Mode Effect and Analysis system (PFMEA).
- Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ/PPQ).
Bachelor’s Degree in Engineering and six or more years of experience as a Manufacturing Engineer; or equivalent combination of education and experience. Experience creating/executing process validation and documentation activities (IQ/OQ/PQ/PPQ) is required. Strong foundation in design, fabrication and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques, test methods including gage R&R analysis, DFx, and Lean/Six Sigma manufacturing principles. Experience with NPI processes (process qualifications/validations, FMEA, First Articles, Design of Experiments, and engineering change requests). Experience with FDA regulations, cGMP regulations, and the pharmaceutical/medical device industry is preferred.
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.
Senior Manufacturing Engineer (NPI) – 1800 Gateway Blvd. Beloit, WI 53511