Overview

As the intraoperative imaging expert, IMRIS, Deerfield Imaging measurably improves patient outcomes through planning, product integration and clinical workflow to give surgeons access to diagnostic quality scans in hybrid operating room suites. IMRIS Surgical Theatres, which uniquely transport MR and CT scanners to the operating room using ceiling-mounted rails are sold globally to hospitals that perform advanced neurosurgical, spinal, and interventional procedures. As we create the world’s most advanced hybrid surgical theatres, we bring together groundbreaking technology and design to elevate not only the medical experience…but the human experience.

We are currently searching for a Released Product Engineering (RPE) Manager to join our R & D team. This role will be performed both on site and remotely as necessary, but will be based in the Greater Minneapolis Twin Cities area, at our Chaska, MN headquarters.

The IMRIS Released Product Engineering (RPE) Manager leads our engineering activities to maintain and improve our released products. As a key member of R&D leadership, the RPE Manger is responsible for all engineering processes after product launch including R&D’s role in CAPA activities, system upgrade planning, and technical support for manufacturing and service. The RPE Manager leads and manages the work of an engineering team of 8 to 10 people across all technical disciplines. They oversee the content and quality of RPE work, including review of the planning, execution and release to production of the team’s work.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Owns the Released Product Backlog prioritization process and RPE Backlog list including regular prioritization of the list based on input from cross-functional sustaining advisors, in order to meet company product improvement, production and quality objectives.
• Initiates RPE projects based on prioritization and resource availability
• Day to day supervision of all RPE staff
• Recruits contract staff for the RPE team
• Delivers regular reports with status and metrics for the RPE backlog, status of active work and resource participation
• Is the R&D representative to company level released product processes such as the CAPA Board, Device Safety Board and Upgrade Planning Board
• Represents R&D on interdepartmental initiatives
• Manages the R&D Lab including oversight of multiple production equivalent MRI systems
• Leads individual RPE projects when appropriate

SUPERVISION RECEIVED AND EXERCISED

• The RPE Manager is a member of the R&D leadership staff and reports to the Senior Vice President of R&D
• The RPE Manager manages the work of approximately 8-10 people across all technical disciplines that maintain our released products.
• The RPE Manager collaborates with R&D Functional Managers to coordinate staff assignment and functional support to RPE.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS

Required Education and Experience

• BS in Engineering
• Minimum of 5 years medical device industry experience
• Technical leadership of cross-functional product design or sustaining engineering projects
• Experience with formal product change processes for medical devices such as CAPA and Design Control

Preferred Experience

• Knowledge of FDA QSR, ISO 14385 and IEC 60601-1
• Demonstrated experience with medical device design transfer
• Project management / project leadership experience

Abilities

• Team oriented – values synergy of group efforts and invests the effort required to create group solutions
• Driven by a sense of mission and clearly articulates goals to achieve specific results. Takes the initiative to complete important tasks
• Ability to coach and lead technical staff
• Ability to communicate effectively cross functionally within R&D and cross-departmentally, including the ability to present R&D work, concepts and issues to senior leadership
• Ability to coach and lead root cause analysis on product deficiency issues
• Ability to coach and lead FMEA on electromechanical systems
• Experience resolving issues with external custom part and assembly partners
• Ability to determine critical paths for multiple issues and prioritize dynamically

Visit our website: www.imris.com

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IMRIS is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.