Medical Device Technical Project Manager

4 weeks ago

Irvine, California, United States Canon Recruiting Group Full time
Job Description

Job Title: Medical Device Technical Project Manager

Reports to: Senior Operations Manager

Location: Irvine, CA - Hybrid

Salary: $120,000 - $150,000 (annually)

The Technical Project Manager will assist in planning, driving, and managing Medical's program resources and schedules, with the opportunity to grow into a Technical Program Manager role over 6-12 months.

Key Responsibilities:

  • Develop and maintain a detailed Project Plan (activities, schedule, cost, resources, partners) in alignment with our product development life cycle.
  • Drive overall project schedule; Address schedule conflicts with cross-functional teams; Maintain schedule alignment and dependencies across all key stakeholders.
  • Direct and manage the performance of a cross-functional core team consisting of key technical/engineering leadership (including Quality, Clinical, Operations, etc.).
  • Communicate frequently with Senior Operations Manager and CTO and provide regular updates on project progress, risks, and strategic impact to senior leadership.
  • Develop strong understanding of the product technology and interdependencies to competently drive project activities and communication.
  • Work across engineering teams (hardware design, algorithm design, software design, etc.) to manage technical effort and design integration.
  • Proactively manage project risks with the technical team by developing and maintaining plans to reduce risks; Manage scope changes; Investigate issues and implement solutions with a sense of urgency.
  • Enable compliance to design control requirement ISO 13485 and FDA 21 CFR 820.
  • Assist in resource planning; Help identify gaps between available and planned resources.
  • Track project costs and ensure projects are managed within budget.

Requirements:

  • BS degree in Engineering or related field required. MS preferred.
  • Minimum 3 years medical device product development experience.
  • Experience developing products that include hardware (optical, electrical, mechanical) and software (firmware, mobile app, cloud) systems.
  • Experience working with quality systems with understanding of elements in design history files.
  • Experience with regulatory submissions (e.g., FDA 510(k)).
  • Knowledge of medical device standards (e.g., ISO 13485).
  • Ability to foster and maintain effective and trusting relationships with team members.
  • Excellent written, communication, and presentation skills.
  • Proficient with MS Project, Smartsheet, or similar software.
  • Proficient with Microsoft Office tools: Word, Excel, PowerPoint.
  • Competencies: Customer focused, team player, persistence/resilience, pro-active with sense of urgency, quick learner, growth mindset.

At Canon Recruiting Group, we value diversity and inclusion in our workplace. We are committed to creating an environment where everyone feels welcome and valued.

We are an equal opportunity employer and do not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The pay range for this position is $120,000 - $150,000 annually. Base pay information is based on market location.

We will consider for employment qualified applicants with arrest and conviction records.

Our range of benefits may include health care and 401(k) savings plans.

For individuals with disabilities who would like to request an accommodation, please email our HR team.

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