Ximedica is an ISO 13485:2012 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley 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. Position: Program Manager Nature of Role: Reporting to the Director of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. The following key attributes are required:
- Flexibility to perform and manage a wide range of activities and willingness to “wear many hats.”
- Outstanding people skills; friendly, confident, competent, great communicator, honest, and sincere.
- Must be a dynamic personality and willing to work within a collaborative team environment.
- Energetic, proactive self-starter who enjoys challenges and variety.
: Sound program management skills including task scheduling, and budget tracking.
- Develop and Maintain schedule, ensure schedule has been reviewed by internal supervisor. Schedule will include resource needs to accomplish tasks. Schedule and resource needs to be submitted to VPPM & VPSO at the beginning of the phase and updated on a monthly basis.
- Ensure proposal deliverables are completed on time and within budget.
- Ensure program is compliant with the Ximedica product development process, including Ximedica’s SOP’s guidelines.
Submit signed proposal and/or PO with program budget breakdown to accounting and business development by accurately completing the project setup sheet at the beginning of each phase.
- Ensure invoicing is done within the 1st 5 business days of the following month. Ensure that deposit invoices are submitted prior to start of program.
- Ensure that any out of scope work is approved by either the client and/or internally. Ensure that additional project codes are utilized to track changes.
Ensure that each PO has a separate job code.
- Ensure that the appropriate filing structure in the WIP/ Smarteam, CTS, etc. is setup.
- Advocate and maintain appropriate resource loadings needed to maintain project deliverables, including budget and schedule.
- Ensure team members are accurately entering their hours into the accounting system on a weekly basis.
- Ensure program profitability.
- Conduct post-mortem with team members and appropriate senior management on each phase during the program.
Ability to organize and communicate high-level presentations to clients, clinicians, and participating teams, as necessary.
- Develop with team, appropriate presentations of activities during each phase of program. Ensure that each presentation is reviewed internally by senior management prior to submitting to client/other.
- Maintain day-to-day relationships with client companies.
- Submit weekly project status dashboards to internal management and/or client.
- Ensure meeting agendas are submitted prior to and utilized during meetings.
Demonstrated ability to direct and manage resources, make decisions, solve problems, exercise good judgment & flexibility and maintain budgets and schedule.
- Ensure that each team member is aware in writing the time (work effort and duration) allotted for activities.
- Coordinate all aspects of program activities, between the client and Ximedica industrial design, engineering, quality, regulatory, testing, documentation, etc.
Ability to communicate with vendors and to proactively monitor internal resources to ensure all products are developed within cost targets and delivered on schedule. Ensure Ximedica is meeting the needs of the client and that the device will be successful in the marketplace. Medical Specific:
- Familiarity in the design of complex medical capital equipment as well as disposable devices.
- 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.
- Manage the design and development of complex electro-mechanical medical devices and equipment.
Additional experience preferred:
- Experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, sheet metal fabrication, etc.
- Experience in leading brainstorming activities.
- 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.
- Understanding of Voice of the Customer research activities and process.
- Bachelor of Science degree preferably in an Engineering discipline, and a minimum of 5 years of experience in consumer product development and/or medical equipment and device development or its equivalent experience is required.
- Please note: JOB CODE #847PVDMN when applying.
Send resume to: [email protected].
EQUAL OPPORTUNITY EMPLOYERXimedica provides equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.