Principal Product Development Project Management Specialist (12 month contract // REMOTE, team based in Plymouth, MN):

Alternative Title: Engineering Project Manager

Team will consider fully remote candidates but there is a preference for candidates available in a hybrid capacity in MN.

Top Preferred Skills:

Experience supporting, coordinating and / or leading projects

Remediation experience (DHF, Regulatory compliance, EU MDR, UKCA)

Experience in engineering development for new and existing medical devices (Design/Redesign, Process Development / Improvement, Regulatory Compliance, Process Validation, etc.)

Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA

PMP Certification or other formal Project Management training and experience

Ideal Management Skills:

• Organization and tracking of deliverables in a MS Project format
• Tracks and accounts for risks in the project schedule and works with the project team to build contingency in tasks where needed
• Able to use data to make informed recommendations.

Years of Experience:

• Seeking candidates with 3-6 years of experience with Project Management
• Candidates should have direct experience with Medical Device Development and Manufacturing activities

Potential Project Activities:

• Product root cause investigations and recall decisions
• Product market expansion
• Remediation of documentation to meet EU MDR/UKCA requirements
• Oversee CAPEX projects to launch new products and scale production
• Manage and execute commissioning and validation activities for new and existing manufacturing processes

Duties:

• Leads or leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management.
• Manages the development and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
• Reviews status of projects and budgets; manages schedules and prepares status reports.
• Monitors the project from initiation through delivery. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.
• Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders.
• Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• project coordination or project management: 3 years (Preferred)
• medical device development: 5 years (Preferred)
• remediation: 2 years (Preferred)

Work Location: Remote

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