156 applicants

Company

Integer Holdings Corporation · 1 day ago

Engineering Program Manager

United States

Full-time

Remote

Senior Level

$98K/yr - $144K/yr

7+ years exp

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Responsibilities

Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Responsible for end to end management and execution of multiple projects of varying complexities, ensuring that all projects are:

Set up and regularly updated in the Oracle ERP system

Accurately forecasted

Adherent to customer agreements, billing events, & milestones

Financially tracked in accordance with established standards for cost management and revenue recognition aligned to Non recurrent Engineering (NRE) and/or sales of sample, prototype, or verification units

Accountable for completing each assigned project within budget and on time, meeting key performance objectives, managing issues to resolution, managing project and scope changes in alignment to what was quoted or agreed to

Partner closely with cross functional leaders to plan, develop, and direct product development and/or engineering projects from inception through successful implementation and hand off to the designated receiving organization

Prepare, monitor, and ensure adherence to master project/development plans, quotes, budgets,

Specifications, and schedules, providing periodic status reports as required for all assigned projects.

Establish Key Performance Indicators, including milestones, as governance for project execution; provide organization, leadership, and guidance to project/program teams, serving as a member for those or other business teams, as assigned

Serve as the primary point of escalation on respective projects. Receive and respond to requests for service or information for project related matters. Prepare for and participate in status meetings (internal/external), and provide updates on the various projects to Integer cross functional management, external customers, and suppliers, as necessary.

Identify and recommend business process improvements to make the existing Program (Project)

Management Office tools more effective and efficient; engage in best practice sharing across stakeholders and PMO functions across the enterprise, reflecting implemented practices into the PMO Manual.

Manage planning and communication with other functions (marketing, quality, regulatory, design assurance, manufacturing, etc.), as applicable, as it relates to project initiatives, policies, etc.

Ensure identified issues or risks related to any of the assigned projects are effectively resolved to represent the best interests of external customers and the patients they serve, internal customers and affiliated functions, and the overall Integer business

Support Integer's commercial team in assessing and providing inputs to new opportunities and quote development, which may involve visits to customer and/or supplier sites to assess technical capabilities and requirements, as well as general project requirements

Actively engage with and leverage the implementation and adherence to Product Development Process (PDP), Manufacturing Transfer Process (MTP), and Technical Development Process (TDP) systems, as applicable

Provide mentoring and training to Associates within the cross functional teams, or others, as required

May manage up to 2 to 3 direct reports, engineers or technicians, ensuring establishment of Goals and Objectives and supporting their respective personal and professional development plans.

Performs other duties as required.

Qualification

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Regulated Product ExperienceFDA RegulationsProject ManagementOracle ERPQuality Management SystemsTechnical Development ProcessProduct Development ProcessManufacturing ProcessesCoaching SkillsCollaboration Skills

Required

Bachelor’s degree in Engineering or related technical field

7+ years of experience, at least 4 in a regulated product environment like medical devices, pharmaceuticals, automotive, and aerospace

3 years in a project management capacity having led multiple projects and project teams

Demonstrated ability to lead team activities

Strong ability to coach

Advanced critical thinking & problem-solving skills

Strong communication, presentation, follow-through, and organizational skills

Ability to effectively work both vertically and horizontally across the organization and cross functionally

Collaboration and conflict resolution skills

Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system requirements that intersect with design control and product development activities

Comprehension of product & process development engineering principles sufficient to allow participation in product and technology development program ideation, scoping, initiation, and execution

Broad experience base with manufacturing processes across multiple products and processes, preferably inclusive of medical components, subassemblies and finished medical devices

Able to travel domestically and internationally, as required (up to 30% at times)