Program Manager Medical Devices

Overview:

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.

Responsibilities:

Essential Functions

• 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

Qualifications:

Basic Qualifications

• 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

Desired Qualifications

• 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

 

Garmin International is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran's status, age or disability.

 

This position is eligible for Garmin's benefit program. Details can be found here: Garmin Benefits