Product Development Engineer
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 Madison, 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 Product Development Engineer will focus primarily on the development efforts of single use and reusable medical device disposables along with handling sustaining activities to support and improve existing products. The position will work closely with Manufacturing and Product Development teams to achieve quality, customer satisfaction, cost, safety, and business goals. The position will be responsible for designing and maintaining medical device disposables for NorthStar’s isotope processing instrument (i.e. custom molded components and assemblies, custom machined components and assemblies, off-the-shelf components, reagents, tubing assemblies, packaging, vials, etc.). The Product Development Engineer will resolve design, manufacturing, and sourcing issues. This includes individually fulfilling these essential functions and potential leadership of small teams including internal and external resources.
Duties and Responsibilities
- Provide engineering support to the project team to design and develop medical devices (disposable and reusable) from concept through market introduction.
- Supports complaint/CAPA/deviation/NCMR/out of specification investigations to determine the root cause of failures and resolve technical issues.
- Coordinate development activities to meet customer requirements.
- Support qualification activities for changes to manufacturing processes at supplier sites and introduction of equipment including tool validation, IQ/OQ/PQ.
Bachelor’s degree in an Engineering discipline (Mechanical Engineering, Biomedical Engineering, Plastics Engineering, etc.) and three or more years of experience; or equivalent combination of education and experience. Familiarity with SolidWorks, FDA regulations, cGMP regulations, and pharmaceutical/medical device industry is preferred.
Madison isn’t just the “Capital City,” it also houses NorthStar Medical Radioisotopes’ Research and Development facilities.
The Madison region is a place where dynamic, talented, innovative and hardworking people want to be. We know this because the region is growing at a faster rate than the state and the nation. Madison, Wis. was named first on Livability’s top 100 places to live in 2014.
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.
Product Development Engineer – 5249 Femrite Drive Madison, WI