Vacancy expired!
Seeking Program Managers with experience in Electrical Engineering, Mechanical Engineering or Software Engineering. You will drive the development of our instrumentation in parallel to that of the product.You will apply your excellent communication skills and passion to lead multi-functional teams to develop ground-breaking products. The team responsible for developing technologies, calibration methodologies and the respective instrumentation for the calibration and validation.Primary Responsibilities
- Manage schedules and lead cross-functional commercialization teams in developing, validating, and documenting customer product, test and process requirements.
- Collaborate with partners, contract manufactures, and specialists to optimize designs for manufacturability and product quality for AM and traditional manufacturing processing of components and related downstream processes such as cleaning, packaging, and sterilization of medical devices.
- Proficiency maintaining design control activities for new product development
- Generates and/or oversees the generation of test protocols, reports and supporting documentation relevant to design control and other applicable regulatory requirements.
- Ensure compliance with documentation guidelines, creates and adheres to strict timeline and project cost requirements, and hold project and design reviews in accordance with product development procedures and customer/project communication requirements.
- Maintain proper design controls, risk management and design history files. Proactively proposes changes to internal procedures based on needs and risk mitigation.
- B.S. in Mechanical or Biomedical Engineering or other relevant engineering field.
- Minimum 5+ years of experience in product design and development for medical devices
- Experience creating and managing project costing and schedules for orthopedic implant design, prototyping and product development.
- Ability to create procedures, work instructions, regulatory forms, and engineering drawings
- Demonstrated ability to solve complex problems, deliver on assigned tasks on time and work with minimum guidance and supervision.
- Strong verbal & written communication skills including ability to present technical information before peers, leadership, surgeons, and outside partners.
- Conventional manufacturing DFM experience required; additive manufacturing and DFAM a plus.
- Knowledge of conventional manufacturing processes and ASTM Standards required.
- Experienced user of PowerPoint, Word, Excel, G Suite and project management tools such as Jira/Confluence.
Vacancy expired!