Engineering Project Manager

Cirtec Medical; Santa Clara (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Cirtec Medical in Santa Clara, CA seeks a Project Manager to lead development and manufacturing transfer of complex medical device components and finished products. The role requires coordinating across groups, managing plans and risks, and communicating with customers.

Ideal candidates have a BS in engineering, 5+ years in medical device PM, and solid knowledge of ISO 13485 and FDA 21 CFR 820. Base pay ranges from $110,000 to $125,000 per year.

Qualifications

• Bachelor's degree in an engineering field with strong device development exposure.
• Experience translating complex technical details into actionable plans and actions.
• Familiarity with regulatory quality systems and design controls.

Responsibilities

• Manage development and manufacturing transfer of complex components and finished medical devices.
• Generate and maintain detailed project plans, task lists, and risk registers.
• Coordinate activities across functional groups to achieve milestones.

Skills

Project management

Communication

Risk management

Technical drawing interpretation

Education

BS in engineering

Job description

Overview

Cirtec Medical is a leading outsourcing partner for complex medical devices, specializing in design and development, precision components, and finished device assembly for Class II and III devices. Our expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. We seek individuals who embrace growth, innovation, and collaboration to better support our clients.

Position Summary

The Project Manager is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Key Responsibilities

• Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
• Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
• Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
• Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
• Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
• Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
• Complies with company, quality and safety standards, policies, and procedures.

Must Have

• Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry.
• Minimum 2 years of experience in project / program management of medical device development.
• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
• Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
• Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.

Good to Have

• Experience with metals processing and Nitinol-based devices preferred

Salary Range

The pay range for this role is $110,000 - $125,000 per year. The starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range may be modified based on market conditions.

Cirtec Medical Corporation considers qualified candidates for employment without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation endorses equal opportunity for all and provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture built on innovation, respect, transparency and communication, and we hope you take pride in being a member of our team. We aim to maintain a great work environment and to keep Cirtec a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans to support you at every career and life stage, including Training and career development, Healthcare and well-being programs (medical, dental, vision, wellness and occupational health), Paid Time Off, and 401(k) retirement savings with company match.