R&D Executive Director, Device Development / Mechanical Engineering

Job Description

The Executive Director of Device Development / Mechanical Engineering will be accountable for overseeing all device-related product development efforts across multiple U.S.-based facilities with direct management responsibility for both individual contributors and people leaders (i.e., managers & directors).

In this role, the Exec. Dir. will serve as a member of the R&D Leadership Team within a function-based R&D organization comprising Systems Engineering, Hardware Development / Elect. Eng., Software Development, Innovation & Technology Development, and Sustaining Engineering.  The U.S. Development Center (i.e., US-DC) operates within a global R&D matrix with responsibility for collaboratively developing products in the fields of Urology, Respiratory, ENT, GI-ET, Gynecology, and Surgical Devices. 
To succeed in this execution-centric role, the Exec. Dir. must be an engaged, collaborative, and proactive product development leader with a proven track record of applying their extensive experience in medical device development to successfully launching complex single-use and reusable products.  The Exec. Dir. will be extensively skilled in Design Controls, product development strategies, and project management / contingency planning.  In addition, the Exec. Dir. will be expected to maintain a deep / thorough understanding of the projects under their purview, as well as the deliverables and milestones associated therewith. 

The Exec. Dir. of Device Development / Mechanical Engineering will function as a senior leader within the U.S. R&D organization. Therefore, it is expected that he/she exhibit the performance and behaviors expected of a role model for our organization.  They must have the willingness and aptitude to coach, mentor, train, and lead her/his team, proactively jump in to help their peers and team wherever appropriate, and ensure unwavering compliance to Olympus’s Core Values (Unity, Integrity, Empathy, Agility, Long-Term View), applicable regulations/standards, and our internal systems. 

The Exec. Dir. of Device Development / Mechanical Engineering will report directly to the Head of the U.S. Development Center (US-DC) and will be expected to provide updates on a regular basis.   Further, the Exec. Dir. must be capable of representing the US-DC, as required, before cross-functional executives.  As such, the Exec. Dir. must be skilled in communicating in a clear and concise manner even when presenting complex and/or difficult topics. 

Lastly, the Exec. Dir. will be expected to support the US-DC as required to enhance our efficiency and effectiveness, as well as support our Global R&D Matrix as required (e.g., represent the US-DC in global working groups, etc.).

Job Duties

* Accountable for the timely and predictable execution of all device / mechanical development efforts (both internal and externally developed) under their purview.

* Proactively engaging with their team to ensure appropriate planning and contingencies are in place to methodically mitigate project issues/risks, achieve project milestones, and launch with predictability.

* Leadership of the R&D resources (Directors, Managers, & Engineering Resources), as well as ensuring project teams have the appropriate and/or capable resources for success.

* Drive project advancement and act with a sense of urgency to ensure projects remain on schedule.

* Build a respectful and energized culture in alignment with Olympus Core Values (Unity, Integrity, Empathy, Agility, Long-Term View).

* Manages expectations of stakeholders and seeks to ensure Head of US-DC is updated in a timely manner so not caught off-guard.

* Apply strategic product development foresight and leadership to all programs; i.e., apply extensive knowledge and experience to ensure product development strategies having a high likelihood of achieving our Quality, Investment, Cost (COGS), and Delivery expectations (QICD).   

* Execute effective resource performance management responsibilities, including: setting appropriate goals, conducting performance reviews, providing timely feedback, as well as executing performance improvement actions when required.

* Operates as a champion for continuous improvement in our practices, policies, and procedures.  

* Builds effective relationships and supports staff and cross-functional leaders.

* Provides leadership and mentoring to R&D staff, as well as general project and product development oversight, to ensure product quality, reliability, and design robustness.

* Maintains a vision for the resources based on skill / competency gaps and ideates solutions, such as training programs or individualized coaching, etc.

* Works collaboratively with cross-functional peers to ensure a high degree of alignment between the US-DC R&D functions.

* Represents the US-DC within the R&D Global Matrix as required (while ensuring an aligned vision with the Head of the US-DC) and supports efforts/initiatives as required.

* When required, capable of diving into project teams to resolve issues, provide support, etc.

* Provides regular updates to the Head of the US-DC through weekly discussions and monthly updates.

* Recruits, develops, and capable of proactively managing staff performance and developing talent.

* Must operate with accountability and ownership, as well as exhibit the behaviors and performance expected of an R&D leader.

* Ability to be onsite, as required and negotiated with manager.

* Performs all other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree in Mechanical Engineering (or equivalent) required. Advanced degrees and/or a track record of continuous improvement strongly preferred.

* Minimum of 20 years’ experience in medical device development.

* Minimum of 10 years’ experience as a people leader.

* Experienced in the design and development of single-use and reusable medical devices; preferably devices compatible with capital equipment (e.g., electro-mechanical instruments) and associated manufacturing methods.

* Experience leading Device / Mechanical Engineering resources and leaders through programs employing multiple sub-teams / workstreams in collaboration with Hardware, Software, and Systems Engineering functions (or the like).

* Experience overseeing and managing both organic product development efforts, as well as externally developed products.

* Skilled in reviewing/refining device requirements, as well as developing test methodologies, to ensure sub-system or device meets its performance requirements.

* Extensive experience in developing and commercializing regulated devices under Design Control (21 CFR 820), ISO13485, ISO14791, ISO10993, etc.) and knowledge of applicable regulations.

* Extensive experience with Verification and Validation testing of complex medical devices.

* Ability to travel domestically and internationally based on team, project, and business needs.

PREFERRED QUALIFICATIONS:

* Experience in a matrixed organization and/or an organization comprising a systems engineering function is strongly preferred.

* Possesses a deep understanding of product development processes, systems, and strategies.

* Ability to guide and mentor staff, motivate for results, and recognize and act on employee issues.

* Ability to work effectively in a multicultural global organization.

* Must have good organization and leadership skills.

* Excellent communication skills (written and verbal), including experience presenting in front of cross-functional executives.

* Aptitude for project foresight and contingency planning. Ability to predict potential design & development issues and implement risk mitigations.

* Has a “can do” positive attitude.