What do YOU need to bring?
A BS degree required PLUS 15 years experience in planning, scheduling, buying and commodity management.
A Proven background in demand/capacity modeling and application. Minimum 5 years experience with MRP systems-preferably SAP. BPCS or MAPICS also good. International supply chain experience required as well as experiencing in implementing S7OP and APICS certification desired.
Sr. Manager, Manufacturing Engineer
Reports to: VP, Manufacturing
My client is a globally positioned, ethically concerned manufacturer of Class III medical devices-they take a sad heart and make it better!
This is a brand new position developed to rapid growth and to accommodate this growing division. This division will set the standard for their overall business within the next 7 years! Essential functions include but not limited to:
Essential Functions include:
Through subordinates, develops, executes and approves/controls items such as: equipment capacity, quality and productivity improvement initiatives, engineering cost center budgets, and related manufacturing performance metrics such as yield, productivity, volumes, cycle time.
Manage design transfer, implementation of yield and productivity goals, engineering changes, manufacturing costs targets, and Continuous Improvement initiatives in manufacturing.
Work with peers, engineers, supervisors and other employees on team projects to solve problems and improve processes and procedures that enhance quality, productivity and cost for existing and new product introductions utilizing Lean Mfg and Six Sigma methodologies.
Responsible for strict adherence to all aspects of FDA/QSR/ISO/GMP requirements applicable for tooling, drawings and documentation.
Establishes departmental priorities, training requirements and compliance, assesses engineering capabilities, talent and is responsible for Manufacturing Engineers performance.
Engage, Lead & Support the engineering function to ensure a smooth transition of new products from research and development to manufacturing.
Champion the development and adoption of new technologies and a data-oriented / analytical approach towards all operational opportunities. Familiarity with SAP
Bachelor’s degree in Engineering or technical field. Minimum of 10 years engineering management experience, preferably in a Class II or Class III device or medical equipment manufacturing environment. Proven experience in Lean/Cellular Manufacturing, Six-Sigma along with strong computer proficiency.
FIELD CLINICAL ENGINEER MANAGER/ Class III Medical Devices
USE YOUR HOME AS A BASE IN LIEU OF RELOCATION!
Our Client is a Globally Positioned, Ethically Sound Leader in Class III Medical Devices Manufacturing.
Although they are based out of the Minneapolis-St.Paul area, the client prefers to hire someone living near a ’gateway city’ or major airport hub as there is 70% travel involved, some international-preferablty in the NE region of the US!
No relocation needed to the corporate headquarters!
This is a very critical and precise position:
Base to $120K plus FCE Bonus Plan + Stock Option/Stock Purchase Plan Eligibility.
You need to take initiative and demonstrate that you can ’lead by influence.’ Also: understand the difference between ’leadership’ and ’management’.
Day to day:
Working within broad objectives from the FCE department, the manager is accountable for assisting and coordinating FCE activities within an assigned geographic area of responsibility.
Provides technical support to medical and sales personnel, management of clinical and research programs, educational activities and general sales support. Interfaces with sales management to efficiently administer the region’s account development requirements.
Identifies and routinely uses the most effective, cost efficient and best business practices to execute process; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise.
Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development.
Responsible for the development of staff, critiques, instructs, mentors, evaluates and coaches staff.
Accountable for the performance of subordinates, maintains a safe working environment, models optimum leadership competencies to inspire an energized, empowered and accountable workforce, has ethical behavior and a favorable community image with an actualization of our client’s Guiding Principles and its divisions management values.
Coordinates field support for the region for all clinical research in the territory. Continually monitors clinical research activities in the region including oversight of the region’s FCE’s in their clinical trial administration, site nomination, site data performance, site patient enrollment volumes and protocol adherence.
Periodically visits with key accounts in conjunction with the local FCE to keep key customers informed about company research and development activities.
Identifies and develops candidates for Sr. FCE/Mentor positions within the assigned region. Effectively manages projects including mentoring, product planning groups, performance improvement initiatives and educational materials.
Works with sales management to develop business in the region by identification of key accounts for the FCE’s to focus clinical research efforts. Coordinates with sales management for account servicing emergencies as situations present themselves
Performs functions and responsibilities related to support of the sales division as available to assist with case coverage, education and case support
Requirements:
BS degree in biological sciences, a related field or equivalent with 10 plus years of progressive clinical experience in cardiology and electrophysiology.
Demonstrated success in driving clinical research, publications as an FCE, patent submissions and new product development contributions are required. Highly developed leadership skills including delegation, database management, team building and document control. Excellent communication skills, problems solving and analytical skills and conflict resolution skills. Ability to travel both within the US and internationally.
Nursing background or skills would be an asset as well as being comfortable relating to physicians-sales background or skill sets are also an asset.
Desired: Advanced credential in a relevant discipline (MS Degree), professional health science certification or designation.