Engineering Program Manager - Medical Devices

Sustaining Engineering Program Manager – Medical Devices


Are you seeking an opportunity to use your skills to do incredibly meaningful work that truly changes the lives of people around the world? Does the idea of meeting the patients you are helping to save excite you?

A Class III medical device company has developed a medical device that is the first of its kind and will literally save thousands of lives. They are looking for a Sustaining Engineering Program Manager to be part of one of the most ambitious contributions to medical technology, the world has witnessed. We are seeking candidates who are currently in Arizona. If you join this revolutionary team, you will be based in Tucson, AZ.
The leadership suite loves to promote from within, are ambitious, and a down to earth and fun group. They have created such an incredible dynamic in the department, that people genuinely love coming to work.

Responsibilities:

Work with cross-functional teams to ensure that design elements (Design Planning, Design Inputs, Design Outputs, Design Verification, Design Validation, Design Transfer, Design Changes, Design Reviews and Product Obsolescence) are properly scoped and met for each sustaining project. This includes planning, requirements generation, specification generation, verification, validation and risk management documentation.
Work with team to assure product changes provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market as well as cost effectiveness.
Facilitate business growth by obtaining regulatory approval of sustaining projects for the currently approved product line.
Develop detailed work elements, project tasks, critical milestones and contingency plans to meet design control requirements and speed to market
Prepare Design History File documents and ensure appropriate design reviews are conducted. Facilitate the Design Control Process ensuring that all phases are successfully accomplished
Function as design verification lead on assigned project teams with accountability for the development, execution, and reporting of verification activities
Report to management on the schedule and status of the project
Facilitate across multiple departments, suppliers and with external consultants to successfully move product design and design changes from feasibility into design outputs, verification/validation and into production environments.
Coordinate with assigned project resources (team members, materials, external contacts) to ensure completion of project activities
Develop and/or manage project budgets to track expenses
Operate inside of an electronic document control system, processing change requests, to drive project documentation to completion
Facilitate meetings, taking action items and meeting minutes
Manage a project schedule through MS Project; track critical path and provide support to team to reach defined milestones
Maintain other project documentation up to date throughout project timeline

Requirements:

2+ years of engineering experience.
Program or product management experience is preferred, but not required.
Experience working with medical devices, preferred.
Will also consider those with experience in aerospace and defense.
Strong problem solving and decision-making skills.
Knowledge of quality management systems.
Must currently reside in, or near, Arizona.
Bachelor’s Degree in Engineering, Engineering Sciences or Business Administration.


• Highly competitive salary + Full benefit package (medical, dental, vision, 401k and more) + great perks + amazing work/life balance •

This work is high impact, high visibility. Rapidly growing company, at the forefront of cutting- edge technology. The possibilities are limitless.

For immediate consideration please apply.


Requirements:

2+ years of engineering experience.
Program or product management experience is preferred, but not required.
Experience working with medical devices, preferred.
Will also consider those with experience in aerospace and defense.
Strong problem solving and decision-making skills.
Knowledge of quality management systems.
Must currently reside in, or near, Arizona.
Bachelor’s Degree in Engineering, Engineering Sciences, or Business Administration

  • Apply with Adecco

Reference number US_EN_2_109982_332591