Project Manager V

KARL STORZ•Goleta, CA

1d•Onsite

About The Position

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.

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 Haves

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.

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.