Project Manager, NRO Development

Biotronik•Oswego, IL

12d•Hybrid

About The Position

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission. Please join us as: Project Manager, NRO Development SUMMARY The Project Manager will coordinate New Technology and New Product Development efforts, consistent with medical device new product develpment customer requirements. The Project Manager will interface with Senior Management, Line Management, and external customers and supplier to assure success against Key Performance Indicators.

Requirements

BS Degree in engineering in the field of Electrical, Biomedical, Mechanical, or related engineering discipline.
Minimum 4 years’ experience in project management of medical devices or similarly regulated industry.
Experience in project management of international and global development teams.
Demonstrated track record of technical project management leadership.
Strong communication skills, with a focus on team collaboration/development.
Strong group facilitation and mediation skills.
Industry-related knowledge of medical device development.

Nice To Haves

PMP or similar certification.
Familiarity with Agile and other project management methodologies.
Direct knowledge of FDA and MDR regulations.
Experience with ISO 13485 and/or 21CFR820 compliant Quality Management Systems.

Responsibilities

Manages international development teams to assure technology and development efforts are achieved in alignment with established project and portfolio commitments.
Develops and manages project plans, schedules, and budgets for NPD and technology projects.
Develops and maintains strong relationship with internal and external suppliers.
Lead the effort to identify, evaluate, and select relevant suppliers to meet project goals.
Interacts with internal and external customers to assure scope of projects meet Voice-of-Customer needs.
Provides regular updates to Senior Management, Product Management, Operations, and other departments to assure project deliverables are on track with intended goals.
Using relevant KPIs, provides risk-based analysis of project to assure that project goals are met within constraints of given budgets and timelines.
Works with Design and Quality assurance, leading the effort to assure medical devices are developed in compliance with relevant Quality Management Systems.
May assist with product and QM audits, as necessary.
Other duties may be assigned at the discretion of the manager.
Work with MST customers as project liaison between the development team and stakeholders.
Coordinate with team leads to drive project and establish estimates of project time and materials.