Technical Project Manager

Brightpath Associates LLC; Longmont (CO); On-site; USD 95,000 - 130,000; Full time

Job summary

Brightpath Associates LLC is seeking a Technical Project Manager to lead medical device design and development projects from planning through delivery.

You will guide technical decision making with sound engineering judgment, ensure adherence to Design Control requirements, and coordinate a cross-functional team to meet project objectives.

Qualifications

• Bachelor’s degree in engineering or a related technical field.
• 5+ years of experience in a technical field (medical device industry preferred).
• 2+ years of experience in project management.
• Knowledge of design control principles, methodologies, and tools used in the medical device industry.
• Solid understanding of ISO 13485:2016 and FDA part 21 CFR 820 regulations is required.
• Excellent communication, leadership, and team management skills.
• Strong computer skills, including proficiency in MS Office.
• Exceptional problem-solving and decision-making abilities.
• Proficient in project management tools and software (MS Project and/or Smartsheet preferred).
• Detail oriented with strong organizational and analytical skills.

Responsibilities

• Develop and manage project plans, timelines, budgets, resource allocation, and risk management.
• Utilize tools to plan tasks, milestones and deadlines.
• Serve as central contact for the project, communicating with stakeholders.
• Coordinate between team, vendors, customers to ensure deliverables and milestones.
• Plan and run project meetings, prepare agendas and summaries.
• Allocate resources to complete projects on time and within budget.
• Monitor task completion and mitigate at-risk tasks.
• Create and maintain design history file documentation.
• Ensure regulatory compliance and industry standards.
• Collaborate with engineers to ensure feasibility and compliance.
• Lead design control reviews to ensure quality and specs.
• Track performance and identify areas for improvement.
• Manage relationships with external suppliers and customers.
• Additional work as defined by leadership.

Skills

Project planning

Team management

Technical communication

Stakeholder management

Design and change control

Problem solving

Technical writing

Education

Bachelor’s degree in engineering or related field

5+ years in a technical field

2+ years in project management

Knowledge of design control in medical devices

ISO 13485:2016 and FDA 21 CFR 820 familiarity

Strong communication and leadership

Tools

MS Project

Smartsheet

Job description

As a Technical Project Manager, you will be responsible for the successful technical management of medical device design and development projects from planning through delivery.

This includes the use of sound engineering judgment to guide technical decision making, ensuring adherence of the project to Design Control requirements, and effective coordination and communication with a cross-functional team to ensure project objectives are met.

• Project planning and execution


• Team management and collaboration


• Strong technical communication skills


• Stakeholder Management


• Design and Change Control


• Problem-Solving


• Technical Writing

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

Essential Job Functions:

• Develop and implement project plans, timelines, budgets, resource allocation, and risk management strategies.


• Utilize appropriate tools to plan project tasks, milestones and deadlines.


• Act as a central point of contact for the project, communicating with stakeholders effectively.


• Liaise between project team members, external vendors, customers, and other stakeholders to ensure deliverables, technical requirements, milestones and deadlines are effectively communicated.


• Plan and facilitate project meetings to align the project team to methods and goals and to track project tasks. Prepare agendas, meeting notes, and project summaries.


• Allocate resources effectively to ensure projects are completed on time and within budget.


• Monitor task completion status to identify at risk project tasks and develop mitigation plans.


• Create and maintain quality regulated design history file documentation.


• Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.


• Understand the technical aspects of medical device development.


• Work closely with engineers to ensure projects are technically feasible and meet requirements.


• Facilitate and participate in design control reviews to ensure product quality and compliance with specifications.


• Track project performance and identify areas for improvement.


• Manage relationships with external suppliers and customers.


• Additional work as defined by executive leadership.

Education and Experience:

• Bachelor’s degree in engineering or a related technical field


• 5+ years of experience in a technical field (medical device industry preferred)


• 2+ years of experience in project management


• Knowledge of design control principles, methodologies, and tools used in the medical device industry.


• Solid understanding of ISO 13485:2016 and FDA part 21 CFR 820 regulations is required.


• Excellent communication, leadership, and team management skills.


• Strong computer skills, including proficiency in using MS Office.


• Exceptional problem-solving and decision-making abilities.


• Proficient in project management tools and software (MS Project and/or Smartsheet preferred)


• Detail oriented with strong organizational and analytical skills.


• Ability to work in a fast-paced and dynamic environment.


• Knowledge of Agile/Scrum methodology is a plus.

Physical Demands:

• Ability to sit or stand for long periods of time.


• Ability to lift, bend or move up to 20 pounds.


• Ability to adjust work schedule to meet deadlines and deliverables.