Program Manager

Switchback Medical; Brooklyn Park (MN); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Health, Dental & Vision benefits

401(k) Plan with company match

Paid Time Off

Parental Leave

Paid Holidays

Job summary

Switchback Medical in Minnesota is seeking a Program Manager to oversee multiple simultaneous product development programs. You will lead cross-functional teams, manage cost, schedule, and performance, and report progress regularly.

The role requires deep familiarity with CFR 820, ISO 13485, ISO 14971, and related quality systems. You will develop project plans, coordinate activities, and drive timely product deliverables.

Qualifications

• Experience leading product development projects within a regulated manufacturing environment.
• Strong understanding of CFR 820, ISO 13485, ISO 14971 and related standards.
• Excellent judgment for logic-based business decisions.
• Ability to trace, drill-down and question activities across functions to drive decisions.
• Experience developing and scaling-up products.
• Knowledge of operations including scheduling, procurement, manufacturing, testing, and quality systems.

Responsibilities

• Lead the development of project plans and coordinate cross-functional teams.
• Ensure customer needs and competitive products are considered throughout development.
• Generate product deliverables and milestones with input from team members.
• Develop and implement recovery plans for schedule variances.
• Track progress against project plans and manage resources and risks.
• Communicate with all levels of the organization and facilitate core team meetings.

Skills

Project management experience

Regulated manufacturing knowledge

MS Office proficiency

Analytical decision making

Prioritization ability

Education

Bachelor of Science Degree in Engineering

Tools

MS Office Suite

Project Management tools

Job description

Description

Summary:

The Program Manager is responsible for the execution of one or more simultaneous products under development. Supervises and provides leadership to multi-departmental product development projects. Overall accountability for all program(s) cost, schedule and performance. Reports team progress and recommendations on a regular basis. Manages Company portfolio of programs as it relates to product development. Works with departments to ensure needs are incorporated in the development plans.

Essential Duties and Responsibilities (but are not limited to):

• Take the lead in the development of the project plans.
• Develop and coordinate the activities of an effectively organized and functioning team.
• Remain aware of customer needs and new competitive products, throughout the product development cycle, and the related impact on project/product acceptance.
• Responsible for generating product deliverables and timeline with specific milestone inputs from the responsible individuals within the team.
• Develop and implement recovery plans for off-schedule and unanticipated eventualities.
• Track progress against the project plan action items.
• Drive teams towards excellence in analysis, decision-making.
• Provide leadership to the team by working to define clear, realistic goals.
• Lead by example with excellent diligence, planning, analysis, and communications.
• Ensure that the team works as a 'team', working for the good of Switchback Medical.
• Help clear barriers to team progress.
• Manage all cross-functional aspects of the program.
• Delegate and manage the tasks of the other functional core team members.
• Apply the appropriate management techniques given project specific needs, risks and differences incore team member skill levels.
• Correct project resource issues, such as performance problems or availability problems.
• Communicate frequently with all levels of the organization. This includes team members (core and extended) and functional managers to ensure that they understand the issues, recommendations, and plans.
• Facilitate the core team meetings. Issue agendas and minutes if necessary.
• Prototype fabrication, assembly and evaluation of devices using a variety of methods.
• Development of bench top product performance tests.
• Perform day-to-day investigational testing and preliminary verification tests.
• Evaluate and design solutions to problems affecting product manufacturability or reliability.
• Interact with vendors, when appropriate, to obtain equipment, components, supplies or services.
• Familiarity with machine shop equipment, rapid prototyping techniques, and basic molding and extrusion methods.

Requirements

Technical Skills:

• Experience in project management (as a team leader) for a product line.
• Thorough understanding of QSR CFR 820, ISO 13485, ISO 14971 and other relevant standards.
• Excellent judgment in making logic-based business decisions.
• Ability to understand, trace, drill-down and question activities and issues in all functional areas and make sound business decisions based upon that data.
• Experience working to develop and scale-up products.
• General knowledge of operations, including scheduling, procurement, manufacturing, test engineering and quality systems.
• Must be familiar with product construction and application.
• Highly proficient with MS Office (Word, Excel, Access, Project and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.

Conceptual Skills:

• Ability to work well with multiple instructions and projects.
• Creative problem solver coupled with good judgment.
• High attention to detail and accuracy.
• Ability to manage and prioritize multiple tasks and remain focused on personal objectives.
• Positive, flexible outlook.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels.
• Proven ability to work effectively alone and in a multi-disciplinary team.

Education/Experience:

• Bachelor of Science Degree in Engineering discipline.
• Minimum of five years of previous project management experience in a regulated manufacturing
• environment.
• Education or experience in process design, development, test and validation.

Summary of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan).
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Short Term Disability (STD).
• 401(k) Plan with company match
• Paid Time Off
• 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 $125,000-175,000/year. Actual compensation will be based on individual job-related knowledge, skills, expertise, and experience.