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$115k–$155k/yr
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Health Savings Account, Flexible Spending Accounts, Employee Life Insurance
Posted 38d ago
~40 hrs/week
Responsibilities
The Program Manager leads cross-functional teams through the medical device product development cycle from concept to commercialization. They are responsible for managing a portfolio of complex initiatives, ensuring projects meet scope, schedule, budget, and quality standards.
Requirements
Requires a Bachelor's degree in a scientific or technical field and at least 10 years of project management experience within regulated industries like Pharmaceuticals or Medical Devices. Candidates must be able to handle sensitive information and work effectively in a fast-paced environment.
Full job description
Description
Job Summary
The Program Manager is responsible for the successful planning, management and execution of complex, usually multi-device medical device product development projects and all applicable standard operating procedures. The Program Manager will lead a cross-functional team consisting of product development, quality, manufacturing, and procurement personnel, through the Product Development cycle from concept to commercialization, as defined by customer development agreements.
Essential Functions
Manage a portfolio of complex initiatives that span one or multiple lines of business
Provide on-site leadership for project team by building and motivating team members to meet project goals, adhering to their responsibilities and project milestones
Full project life cycle ownership: successful project delivery will include meeting or exceeding customer expectations with respect to project deliverables
Report on project success criteria results, metrics, test and deployment management activities
Work creatively and analytically within Resolution Medical’s problem-solving environment demonstrating teamwork, innovation and excellence
Participate in establishing practices, templates, policies, tools and partnerships to expand and mature these capabilities for the organization
Support preparation of estimates and develop detailed project plans for all phases of the project
Procure adequate resources to achieve project objectives in planned timeframes
Provide status reporting regarding project milestones, deliverable, dependencies, risks and issues, communicating across leadership
Demonstrate a functional acumen to support how solutions will address customer goals while maintaining alignment with Resolution Medical and industry best practices
Manage project scope and changes
Manage ongoing quality control and participate in quality issue resolution
Define the Statement of Work and Specifications for the requested goods and services
Develop and manage all aspects of project and program engagement from planning, external vendor relationships, communications, resources, budget, change, risks and issues
Provide progress reports as requested by key stakeholders
Coach, mentor, motivate and supervise project team
Ensure that projects and programs are proceeding according to scope, schedule, budget and quality standards
Support continued development of best practices, templates, policies, tools and partnerships to expand and mature these capabilities for the organization
Support company finance, accounting, human resources, and quality as necessary to ensure compliance with requirements
Requirements
Education, Experience, Required Skills
Minimum of a Bachelor level degree in a Scientific or Technical Field and 10+ years or more experience in regulated industry, such as Pharmaceuticals or Medical Devices
Minimum of 10 years Project Management experience within a Regulated Industry such as Pharmaceuticals or Medical Devices
Ability to handle and be trusted with confidential and/or sensitive information
Able to work in a fast-paced, constantly changing environment
Ability to be flexible and to handle multiple projects in an organized, timely manner
Able to problem-solve, work under pressure, and to effectively manage stress
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 25 pounds at times
Must have excellent hand-eye coordination
Ability to differentiate between colored wires, tabs, and electronic components preferred
Must wear gown, gloves, ear protection and other personal protective equipment when applicable
Summary of Benefits
Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
Flexible Time Off Program
Paid Parental Leave
Paid Holidays
Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.
Compensation
The typical base pay range for this role is between $115,000-155,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
Related keywords
Medical DevicesPharmaceuticalsRegulated IndustryProduct DevelopmentCommercializationStandard Operating ProceduresStatement of WorkProject MilestonesQuality Issue ResolutionCross-functional TeamPortfolio ManagementComplianceTechnical Field
Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry with the Highest Quality and Reliability, Exceptional Customer Service, and with the Resolution to continuously improve life.
Resolution Medical designs, develops, tests, and manufactures medical devices and components in collaboration with its customers.
Offices: 42 Northern Stacks Dr NE, 200, Minneapolis, Minnesota 55421, US · Kennedyplein 10-11, Eindhoven, 5611ZS, NL
ManufacturingResearch & DevelopmentClass 10,000 Clean RoomsLean Manufacturing and Six SigmaPrototypingSterile Kitting & PackagingCathetersCardiac & Neuro LeadsPre-clinical researchQuality & Regulatory
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