We are seeking an experienced Project Manager V to lead complex Hardware and/or Software product development initiatives within a fast-paced MedTech environment. This individual will be responsible for driving projects through all phases of development, from concept and feasibility through production release and sustaining engineering support, while ensuring alignment with quality, timeline, and cost objectives.
Key Responsibilities
- Lead Hardware and/or Software product development projects from concept through production release.
- Manage project timelines, budgets, risks, and overall product quality.
- Coordinate cross-functional teams in an Agile development environment.
- Partner with Product Management to define project scope, specifications, and cost targets.
- Oversee prototype builds, pilot production, and manufacturing transitions.
- Ensure compliance with applicable ISO, GMP, and medical device quality standards.
- Identify project risks and implement mitigation strategies to maintain project success.
- Collaborate with Purchasing and Manufacturing to support supplier qualification and production readiness.
- Support sustaining engineering activities and continuous improvement initiatives.
- Provide training and support during prototype and pilot manufacturing builds.
- Travel to beta sites and support product evaluations in clinical environments.
- Participate in Engineering Change Board meetings and related project activities.
Requirements
- Bachelor’s, Master’s, or PhD degree in Electrical Engineering, Physics, Electrical Computer Engineering, or related technical discipline.
- 10–12 years of direct experience in project management, manufacturing, or design engineering.
- Strong knowledge of project management methodologies and cross-functional leadership.
- Experience managing both Hardware and Software development projects.
- Proficiency with project scheduling tools such as MS Project, Planisware, or equivalent.
- Experience with Agile methodologies, Agile ceremonies, and associated tools.
- Excellent written and verbal communication skills with the ability to work effectively across all organizational levels.
- Strong organizational skills with the ability to manage multiple priorities and deliver on commitments.
- Knowledge of medical device quality system regulations and standards, including:
- FDA Quality System Regulation (21 CFR Part 820)
- ISO 13485
- ISO 9001
- Ability to travel globally, including to beta test sites and clinical operating room environments.
Nice to Have
- IPMA or PMP Certification.
- Previous experience within the medical device industry.
- Familiarity with KARL STORZ imaging technologies and medical visualization systems.
- Experience supporting manufacturing transfers and sustaining engineering activities.
- Strong continuous improvement and process optimization background.
What You'll Need to Succeed
- Exceptional leadership and interpersonal skills with the ability to motivate and influence teams without direct supervisory authority.
- Strong problem-solving and risk management capabilities.
- Ability to collaborate effectively with stakeholders ranging from production staff to executive leadership.
- Self-motivated approach with minimal day-to-day supervision.
- Ability to establish and track SMART goals to ensure successful project execution.
- Strong attention to detail and commitment to delivering high-quality results in a regulated environment.
What We Offer
- Opportunity to work on innovative medical technologies that improve patient care worldwide.
- Collaborative, mission-driven work environment within a global MedTech organization.
- Exposure to cross-functional teams and global operations.
- Career growth opportunities within a leading medical device company.
- Competitive compensation and comprehensive benefits package.
KARL STORZ Company Overview
KARL STORZ is a globally recognized, family-owned MedTech company dedicated to advancing minimally invasive surgery and medical visualization technologies. With a strong culture of innovation, collaboration, and quality, KARL STORZ develops cutting-edge solutions that support healthcare professionals around the world. The company combines the agility of a family-owned organization with the scale and impact of a global industry leader.
