Engineering Project Manager

Job Details

Experienced

Legal Address - Longmont, CO

Legal Address - Longmont, CO

4 Year Degree

Engineering

Job Posting Date(s)

04/23/2025

05/16/2025

Description

Engineering Development Project Manager

As an experienced Project Manager, you will be responsible for the successful planning, execution, and delivery of projects within defined timelines, budgets, and quality standards for our Class II/Class III medical device development and manufacturing company.

You will work closely with cross-functional teams to ensure project objectives are met and ensure effective communication and coordination throughout the project lifecycle.

Organizational Competencies & Cultural Values:

The mission of every employee at Osypka Medtec is to serve, support, and improve the lives of our patients and 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.

General Competencies:

Project planning and execution

Team management and collaboration

Medical device technical and industry knowledge

Stakeholder management

Quality control and risk management

Budget and resource management

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 manage project plans, timelines, and budgets.

Lead cross-functional teams (engineering, manufacturing, and quality).

Ensure projects adhere to relevant standards and regulations (e.g. FDA, ISO, etc.).

Manage project risks and issues, developing mitigation strategies.

Track project progress and provide regular updates to stakeholders.

Manage scope and scope creep effectively with both internal and external stakeholders.

Understand the technical aspects of medical device development.

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

Participate in design reviews and testing activities.

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

Facilitate communication and collaboration between different departments and teams.

Manage relationships with external suppliers and clients.

Ensure projects comply with relevant quality management systems (e.g., ISO 13485:2016).

Manage the development implementation of validation plans.

Work with quality and regulatory personnel to ensure products meet regulatory requirements.

Develop and manage project budgets.

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

Identify and resolve budget issues.

Identify opportunities for process improvement and implement changes to enhance efficiency and effectiveness.

Track project performance and identify areas for improvement.

Education and Experience:

Bachelor’s degree in engineering or a related field.

PMP certification or equivalent is highly preferred.

Proven experience in project management, preferably in the medical device industry.

Familiarity with project management methodologies (e.g., Agile, Waterfall).

Strong understanding of medical device development processes and regulations.

Excellent leadership and team management skills.

Strong communication, negotiation, and stakeholder management skills.

Exceptional problem-solving, analytical, and decision-making abilities.

Proficient in project management tools and software.

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

Physical Demands:

Ability to sit or stand for long periods of time.

Ability to lift, bend or move up to 25 pounds.

Ability to adjust work schedule to meet deadlines and deliverables.

Compensation:

$87,000 to $118,000 Annually to start, depending upon experience

Paid Vacation

Paid Holidays

Paid Sick Leave

Partial Payment by Company of Group Health, Dental, and Vision Insurance

401(k) with limited company matching

Qualifications

Engineering Development Project Manager

As an experienced Project Manager, you will be responsible for the successful planning, execution, and delivery of projects within defined timelines, budgets, and quality standards for our Class II/Class III medical device development and manufacturing company.

You will work closely with cross-functional teams to ensure project objectives are met and ensure effective communication and coordination throughout the project lifecycle.

Organizational Competencies & Cultural Values:

The mission of every employee at Osypka Medtec is to serve, support, and improve the lives of our patients and 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.

General Competencies:

Project planning and execution

Team management and collaboration

Medical device technical and industry knowledge

Stakeholder management

Quality control and risk management

Budget and resource management

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 manage project plans, timelines, and budgets.

Lead cross-functional teams (engineering, manufacturing, and quality).

Ensure projects adhere to relevant standards and regulations (e.g. FDA, ISO, etc.).

Manage project risks and issues, developing mitigation strategies.

Track project progress and provide regular updates to stakeholders.

Manage scope and scope creep effectively with both internal and external stakeholders.

Understand the technical aspects of medical device development.

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

Participate in design reviews and testing activities.

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

Facilitate communication and collaboration between different departments and teams.

Manage relationships with external suppliers and clients.

Ensure projects comply with relevant quality management systems (e.g., ISO 13485:2016).

Manage the development implementation of validation plans.

Work with quality and regulatory personnel to ensure products meet regulatory requirements.

Develop and manage project budgets.

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

Identify and resolve budget issues.

Identify opportunities for process improvement and implement changes to enhance efficiency and effectiveness.

Track project performance and identify areas for improvement.

Education and Experience:

Bachelor’s degree in engineering or a related field.

PMP certification or equivalent is highly preferred.

Proven experience in project management, preferably in the medical device industry.

Familiarity with project management methodologies (e.g., Agile, Waterfall).

Strong understanding of medical device development processes and regulations.

Excellent leadership and team management skills.

Strong communication, negotiation, and stakeholder management skills.

Exceptional problem-solving, analytical, and decision-making abilities.

Proficient in project management tools and software.

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

Physical Demands:

Ability to sit or stand for long periods of time.

Ability to lift, bend or move up to 25 pounds.

Ability to adjust work schedule to meet deadlines and deliverables.

Compensation:

$87,000 to $118,000 Annually to start, depending upon experience

Paid Vacation

Paid Holidays

Paid Sick Leave

Partial Payment by Company of Group Health, Dental, and Vision Insurance

401(k) with limited company matching