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SR. OPERATIONS MANAGER-- INNOVATION AND NEW PRODUCT DEVELOPMENT-MEDICAL DEVICE

BOSTON, MA
The leader will play a critical role in building the systems and establishing a team to enable successful delivery of pre-production units that will support a critical program for the company. The ideal candidate will have a proven track record of excellence and passion for Operations and introducing new products/processes within the medical device industry. A key element of this experience is in leading and navigating cross-functional relationships and inspiring collaboration throughout the organization.
 
This role includes two primary areas of responsibility: establishing and managing the manufacturing organization and delivering product builds supporting New Product Development (NPD) in the Andover R&D COE.
  • Establishing and Managing the Manufacturing Organization:  Responsible for providing functional and administrative leadership for the Operations organization. The individual will drive the competency development, associate engagement and development, and recruiting efforts necessary. This role is accountable for establishing the 3-year strategy and managing an annual budget of $3 – 5 M.
  • Support of Innovation and New Product Development: Responsible for supporting the necessary activities to produce product on EWO for design verification, clinical trials, and design validation. In addition, this role will set and manage to the appropriate production metrics. This role is also responsible for implementing the necessary systems and processes cross functionally with Quality to deliver against product and industry requirements.
 
Essential Duties:
  • Drive the operation of assembly manufacturing to comply with schedules, highest safety standards and annual improvement in quality and total cost.
  • Actively participates in the planning of new product introductions.  Emphasis will be placed on the ability to achieve rapid implementation of new products, while meeting quality goals and productivity ramp-up curves.
  • Plans for manufacturing to achieve the strategic objectives, and organizes the manufacturing resources to be superior to competitors in the key strategies adopted.
  • Communicates clearly to the plant staff the business goals and objectives of production operations and provides reports to reinforce the achievement of these goals.
  • Participates in the prioritization and management of plant engineering projects.  In conjunction with the Engineering Leader, assures appropriate alignment with business strategies.
  • Establishes and oversees the activities of multi-functional teams including all plant functions as required to achieve desired goals.
  • Ensures the appearance of all manufacturing areas are maintained on a daily basis in accordance with all applicable requirements and in-line with the image we want to portray to everyone who sees our facility.
  • Analyzes and controls manufacturing schedules to assure compliance with the master schedule issued and reviews performance against the schedule.
  • Oversees the preparation of annual operating and capital budgets for all manufacturing departments to assure attainment of the approved budget.
  • Develops and maintains procedures for waste reduction, improved efficiency and cost reduction programs relating to manufacturing departments.
  • Originates or assesses measures designed to improve production methods, equipment performance and quality of product.
  • Interprets company policies and production procedures to subordinates and directs their activities.
  • Responsible for associate motivation, the maintenance of good associates’ morale and disposition of associate complaints.
  • Analyzes and makes required changes in materials, manning and production when schedules are altered.
  • Ensures compliance with all applicable regulatory requirements including, but not limited to ISO and FDA standards.  Also works in collaboration with the Quality Manager to drive continuous improvements’ in the plant’s quality system.
  • Works collaboratively with Engineering and the site’s Safety Committee to enhance the plant’s safety culture and ensure a safe work environment.  Ensures full compliance with all applicable local, state, and federal safety standards.
  • Create and maintain a safe, secure, and sanitary work environment in compliance with applicable regulations (governmental bodies and BD).
 
Functional Capabilities:
  • Strong communication skills, action-oriented and result-driven while being customer-focused.
  • People-oriented and a team focused leader with a demonstrated Servant Leadership mentality.
  • Knowledge of LEAN Six Sigma and experience with continuous improvement/change management.
  • Basic knowledge of Quality Management Systems especially ISO 13485.
  • Basic knowledge of EU-MDR Regulation 2017/745.
 
Educational Requirements:
  • Minimum of a Bachelor’s Degree required, technical related field desired (i.e. mechanical, biomedical, manufacturing engineering).
  • Masters of Business Administration (MBA) strongly preferred.
 
Experience:
  • Manufacturing experience with manual process and semi-automated equipment necessary; medical device experience preferred.
  • Minimum 15 years of overall experience required.
  • Minimum 5 years of experience in production environment or equivalent.
  • Minimum 5 years of team building and leadership experience with direct reports.
  • Minimum 3 years of experience within new product development or equivalent.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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