Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minnesota, San Francisco, Los Gatos, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products. We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Working out of our Providence, RI headquarters, the Program Manager - Manufacturing will manage and execute design and development programs for complex electro-mechanical medical devices in accordance with the client and development team goals, with a particular focus on the transfer of products from development phases into production .
In this role you will:
- Work with the technical team and department heads to identify the work required to achieve technical milestones
- Maintain schedule, including resource needs to accomplish tasks, ensuring deliverables are completed on time and within budget
- Identify and manage unplanned/out of scope activities appropriately
- Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines
- Organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary
- Maintain day-to-day relationships with client companies, ensuring Ximedica is meeting client needs
- Support customers' interests by specifying the research needed to obtain market information.
- Refine product strategy based on cross functional input from legal/business/regulatory requirements, market trends, medical evidence, and technology landscape.
- 7-10 years of experience in product development
- BA/BS degree in Engineering or related technical field, or equivalent practical experience
- Experience with new product introduction including transfer of development programs into commercial production.
- Experience with sustaining engineering of existing product lines, especially identifying and managing changes to design and process validation.
- Experience with managing change control procedures and the impact on WIP, inventory disposition, product version control and part obsolescence.
- Familiarity with manufacturing engineering activities such as assembly procedures, qualifying test fixtures, in-process testing and factory acceptance testing.
- Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge
- Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.
- Understanding of Industrial Design & research activities and their interface with engineering.
- Understanding of Mechanical engineering development process utilizing 3D CAD or related engineering software techniques
- Understanding of electronics and software development
- Experience transferring products to a Contract Manufacturer (CMO) or working for a CMO desired
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines and to work collaboratively with cross-functional teams. Ideal candidates will be high-energy, self-starters with strong communication skills, business acumen and assertive decision-making ability, in addition to flexibility to multi-task and perform a wide range of activities. Excellent computer skills, including MS Office proficiency.
Please send resume to: [email protected]