Project Manager
$117,000–$130,000 year
On-siteSanta Clara, California, United States
Job Summary
Manage timelines and responsibilities for select projects within the growing portfolio, coordinating tasks across engineering, design, clinical, manufacturing, and regulatory functions to ensure alignment with business goals. Lead or participate in cross-functional meetings from project initiation through launch, actively identifying schedule impediments and streamlining activities while maintaining compliance with worldwide regulatory requirements including FDA QSRs and ISO standards. Create and implement metrics to track team commitments, support the Quality System for non-conformances and design changes, and act as a gatekeeper to hold documentation from shipment in the event of potential regulatory non-compliance.
Required Qualifications
- Bachelor's degree in related field, preferably biomechanical or mechanical engineering degree
- 4+ years of project management experience within the medical device industry
- Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971)
- Ability to communicate effectively in written and oral interactions
- Excellent reading, writing, and analytical skills
- High integrity, sound character, a tremendous work ethic and the passion to succeed
- Professional 'can do' attitude
- Ability to think of ways the project impacts the entire organization
- Ability to continually ask questions to fully understand each project and be able to communicate details to each team member
- Authority to hold any product or Quality documentation from shipment or further processing in the event of potential non-compliance
- Responsibility and authority to report any instances of non-compliance to Quality and/or Regulatory and the respective management team
Desired Qualifications
- Experience in orthopedics
- Spine experience
- Design and change control experience
- Cross functional support experience across R&D with development of new products to launch, Clinical, Manufacturing, Engineering, IT, Operations and other functions
- MS Project and managing project schedules
- Track record for leading successful initiatives through innovative solutions and cost-effective methodologies, followed by product support and improvement
- Passion for supporting an emerging company and sustaining high growth through engineering support
- Basic cross-disciplinary understanding of a medical device business emphasized on engineering, manufacturing, operations, R&D, clinical and regulatory and quality assurance
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