Program Manager Medical Devices

Garmin International, Inc. • Olathe, KS

2d • Onsite

About The Position

We are seeking a full-time Program Manager Medical Devices in our Olathe, KS location. In this role, you will be responsible for serving as a leader and mentor for successful medical device product lifecycle activities and/or process initiatives through documenting and coordinating the implementation of regulatory requirements and leading moderately complex programs per medical device processes. This role also analyzes post-market surveillance trends, identifies key changes in regulation, and acts as primary program support for one or more regulatory jurisdictions.

Requirements

• Bachelor's Degree in a technical discipline AND a minimum of 2 years of relevant experience OR an equivalent combination of education and relevant experience
• Excellent academic qualifications (cumulative GPA greater than or equal to 3.0 as a general rule)
• Demonstrates ability to analyze a problem to root cause, brainstorm/offer solutions, align with stakeholders and execute
• Demonstrates full use of accepted standards and procedures
• Demonstrates proficient use and knowledge of medical device regulation
• Understands production and operations issues as they relate to medical device program management
• Applies Garmin’s Mission, Vision, Values and Quality Policy and exhibits enthusiasm for and a desire to see Garmin succeed
• Demonstrates excellent time management, organizational and follow-up skills
• Demonstrates a sense of urgency, commitment, and focus on the right priorities in developing solutions in a timely fashion
• Demonstrates strong and effective verbal, written and interpersonal communication skills
• Ability to execute well-defined, moderately complex tasks and/or medical device programs
• Ability to drive the various elements of assigned tasks and/or medical device programs forward
• Able to offer some suggestions to improve processes
• Ability to perform as a medical device program leader who drives the overall progress of assigned tasks towards completion
• Capable of mentoring PM Level 1

Nice To Haves

• Involvement with programs subject to regulated processes and quality management systems
• Knowledge of FDA medical device quality system regulation (QSR) and requirements
• Knowledge of European medical device regulation (EU MDR)
• Knowledge of medical device IEC/ISO standards
• Relevant job experience and/or training with one or more of the subjects listed above

Responsibilities

• Development and management of requirements/specifications and traceability to testing
• Anticipates regulatory obstacles and emerging issues throughout development and drives solutions with other members of regulatory and related teams
• Coordinates QMS activities to support the achievement of milestones
• Generates documentation to be submitted to various governmental regulatory agencies to secure approvals to market products in secondary regions
• Assists in management of usability/clinical study activities
• Develops training plans/activities
• Performs tool validation activities against established processes
• Reports on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product or process
• Assists with generating corrective/preventive action (CAPA) plans and participating in internal audits
• Consistently provides clear and accurate documentation and understands level of detail necessary to ensure accurate reporting
• Identifies and resolves conflicts through understanding of interdependencies of and development of effective relationships between the development teams, other Garmin teams/departments, and external entities (e.g. customers, suppliers, etc.)
• Provisions the timely documentation of clear scope (detailed assumptions, internal/external/regulatory requirements), objectives/targets, validation needs, resource estimates (costs, timing)
• Leverages advanced communication skills to ensure team members/stakeholders are appropriately informed, leads tradeoff discussions and drives decisions to keep program moving forward
• Supports creation and maintenance of complex timelines and milestone tracking, including application of program metrics and risk management principles to identify and mitigate schedule impacting items
• Drives development and issue resolution through identification of risks/issues, creation of mitigation plans and identification of issues which impact other products
• With some guidance, performs market research in support of product definition and/or business development initiatives
• Provides reliable solutions to a variety of problems using sound problem solving techniques
• Identifies and resolves issues/risks using proper tools and techniques, including support of root cause and corrective actions for given problems
• Leads small to mid-size medical device program activities as part of a greater program and may lead larger program initiatives
• Collaborates and adds value in medical device design reviews
• Makes substantial contributions to determine feasibility of medical device program goals/objectives and ensures clear documentation of scope; applies knowledge in evaluating proposed program initiatives
• Communicates status of work clearly providing visibility to supervisor and key stakeholders

Benefits

• Garmin's benefit program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level