Product Development Engineer - Medical Device

Job Title - Systems Engineer - NPD Location - New Kensington PA Length - Contract (12 Months+) Description - Job Responsibilities: Conducts in-depth system analyses and performance assessments, leveraging advanced modeling and simulation techniques to identify optimization opportunities and mitigate risks, working under limited supervision. Synthesizes insights from cutting-edge research and industry trends to inform system design decisions and drive continuous improvement initiatives within

Requirements: Minimum required Education: Bachelor's / master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent. Minimum required Experience: Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent. Minimum required Certification: N/A Preferred Education: N/A Preferred Experience: N/A Preferred Ce

Summary Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR). Competence in risk management tools (DFMEA, pFMEA) and traceability from

Senior Scientist, IVD Test Dev. We are seeking a highly skilled Senior Scientist, IVD Test Development to lead in-vitro diagnostic assay development and validation programs within a regulated environment operating under design control. The successful candidate will provide scientific and strategic leadership for complex projects, driving assay innovation and overseeing verification and validation activities in support of regulatory submissions including PMA, 510(k), and IVDR. Title: Senior Scien