Technical Project Manager - Irvine, CA (Hybrid)

Job Title: Medical Device Technical Project Manager

Reports to: Senior Operations Manager

Location:Irvine, CA - Hybrid

(The salary range represents a general guideline; however, we consider a number of factors when determining base salary offers such as the scope and responsibilities of the position, geographic location and the candidate's experience, education, skills and current market conditions.)

POSITION SUMMARY

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.

MAJOR RESPONSIBILITIES

*This list is not all inclusive. Additional duties will be assigned as needed.

• 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.); Engage with team to maintain alignment with project priorities, goals, and key milestones; Ensure adequate visibility, communication, and feedback.
• 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.

KNOWLEDGE, SKILLS AND ABILITIES

The Technical Project Manager has working knowledge of medical device design and development, and is experienced in planning development activities and managing resources and schedules. The Technical Project Manager is expected to drive the technical team toward meeting project goals while staying on schedule and in budget. The Technical Project Manager must be able to solve complex project problems where often times analysis of technical data and systems, project constraints, budget constraints and interpersonal relationships are required. The Technical Project Manager effectively applies project management and planning skills to manage risk, identify critical paths to develop and drive long term plans to meet deadlines and goals. This person may act as lead/primary contact on various projects and interact with all levels of internal and external personnel. The Technical Project Manager understands that mistakes at this level have increased significance, causing rescheduling or adjustments and is expected to escalate problems to the appropriate stakeholders before or as soon as they arise, as well as make recommendations and develop plans of action. The Technical Project Manager consistently exercises independent judgment and discretion in matters of significance.

EDUCATION & EXPERIENCE

• 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.

#IND1

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does 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 listed above. 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.