The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a/n R&D Process Management Lead, located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The R&D Process Management Lead is responsible for developing & implementing systems & programs to improve & maintain product development, design control processes & procedures; Optimizing partnerships with external design service providers for accelerated product innovation; Responsible for the overall management and effectiveness of the Design Review Process; Acting as Design Control Systems Champion; Identifying, prioritizing, and implementing transactional process improvements through the effective use of Process Excellence methodology (Six Sigma, Lean, and Design Excellence);Achieving/maintaining quality system compliance as well as New Product Development [NPD] process integration.
KEY JOB RESPONSIBILITIES:
Write quality system documents to guide design control compliance for R&D & its support organizations. Lead continuous improvement efforts in product development to achieve annual division goals & objectives. Develop & implement training programs to maintain ISO, cGMP & QSR awareness & knowledge for all product development & support associates. Act as R&D spokesperson for key customer & special guest visits. Benchmark best practices from companies who are recognized as leaders. Organize, support & complete follow through on internal & external design control corrective action plans & support objective evidence to close. Communicate information department-wide on regulatory, lessons learned & procedure updates. Partner with Compliance, Supplier Management, External Manufacturing, and other partner groups as required to achieve/maintain approval status for external design service providers. Partner with R&D Project Teams to expedite quality system compliance of external design service providers. Participate as a team member/Subject Matter Expert (SME) on process improvement initiatives as required.
Other responsibilities may be assigned & not all responsibilities listed may be assigned.
SUPERVISORY RESPONSIBILITIES: No direct reports. May participate in supervising temporary associates &/or consultants.TRAVEL REQUIREMENTS: Domestic & international overnight travel, as required.
EDUCATION / DEGREE REQUIRED:
A minimum of BA/BS degree in business, quality or engineering related disciplines or equivalent work experience required.
KEY SKILL / KNOWLEDGE REQUIREMENTS:
Good working knowledge and understanding of medical device regulations: FDA (Food & Drug Administration), ISO (International Organization for Standardization, MDD (Medical Device Directive)Required; Communication - written & verbal - all levels; Analytical & technical skills, preferred; Capable of managing multiple & competing projects, required; Conflict management skills, required; Six Sigma (DMAIIC) or Lean training in transactional processes, required; Green Belt certification preferred, Black Belt certification desired.; Decision-making using a fact-based approach, preferred; Detailed product & procedure knowledge, preferred; Self-starter; Highly motivated; Facilitation skills; Change management, preferred; Configuration management, preferred; Ability to develop & lead training programs, required; Ability to thrive in uncertain & ambiguous circumstances, preferred; Organization & time management skills, required; Able to prioritize work assignments & be multitasked; Technical writing & reading comprehension, required; Project management skills, preferred; Values & behaviors consistent with credo; Problem analysis & solving skills; Business judgment & maturity
Personal computer software - Windows: applicable word processing, project planning, presentation, e-mail, flow charts & spreadsheet software. Work knowledge of statistical analysis software (such as Minitab)
A minimum of 7+ years experience in multiple company & industry environments, preferred. A 2+ years in relationship management role with a background in Product Development, Supplier Management, Customer Service and/or Quality, required. Experience in a regulated environment required. Previous Supervisory experience, desired. CMII methodology certification, preferred. Demonstrated experience in design reviews, preferred. PLM system experience, with implementation experience, preferred.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
Johnson & Johnson is committed to diversity and invites all interested candidates to apply for positions of interest. EOE M/F/D/V
Please note: In order to be considered eligible for an interview, candidates must apply online through the appropriate web portal.
North America-United States-Ohio-Cincinnati
Ethicon Endo Surgery Inc (6041)
Yes, 10% of the time
Johnson & Johnson Family of Companies
- 2 years ago - save job