Technical Project Manager

OSYPKA MEDTEC INC•Longmont, CO

13d•$120,000 - $148,000

About The Position

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. The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of patients and our customers by adding value through innovative quality medical devices and services. Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world. 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.

Requirements

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.

Nice To Haves

Knowledge of Agile/Scrum methodology is a plus.

Responsibilities

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.