Are you a leader that has developed strong teams to optimize manufacturing processes and product quality? Are you a leader that has created team strategy and alignment, strengthened organizational capabilities, and driven focused execution to achieve critical goals and milestones? Do you live daily to Attract, Retain and Develop a high performance team to deliver the best value for our customers through creative solutions?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named one of the “Most Trusted Companies”, has an opening for a Senior Manager of Manufacturing Engineering.
What You Will Do: The position of Senior Manager of Manufacturing Engineering will lead the creation of a world class manufacturing operation, grounded in the principles of Lean Manufacturing and Toyota Production Systems. The Sr. Manager leads a technical staff tasked with providing sustaining production support, performing advanced manufacturing engineering / process development within new product development, and implementing continuous process improvements. This role requires personnel management skills, project management skills, and technical skills. The Sr. Manager will ensure the right talent is attracted to the team, work to develop direct reports to support the needs of a growing business, and seek to retain all critical teammates. The Sr. Manager will set strategic direction for the manufacturing engineering team, assess current gaps and build organizational capabilities with an eye to the future, and ensure tactical execution to accomplish stated goals and milestones. A proven ability to work cross-functionally is required. The Sr. Manager will ensure the manufacturing engineering team's adherence to company procedures, FDA regulations, ISO regulations, and other applicable standards. To be effective, a general understanding of the entire business (manufacturing, quality, R&D, finance, marketing, clinical, regulatory, etc.) is needed.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a strong team of dedicated experts and leaders in the medical device industry who will support your continued growth. You will learn from your fellow Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential leader who will be key in driving profitability in our manufacturing business, while consistently improving the quality and capability of our manufacturing processes.
What Success Looks Like:
Lead the organization to be a world-class manufacturing operation through the implementation of Lean Manufacturing and Toyota Production Systems principles.
Lead the Manufacturing Engineering team to build a culture of continuous improvement and waste elimination, while consistently improving product quality.
Build relationships and work closely with peers in Production, Quality Engineering, Quality Control, Regulatory, Marketing, and R&D on a daily basis to keep manufacturing running, to make improvements to current processes, and to transfer new products into manufacturing.
Ensure that the change management process is executed with rigor on changes made to the production environment, using sound engineering judgement and testing / validation to support the change.
Ensure that required teammates are tasked to oversee the development and implementation of new products and processes during the new product development process.
Responsible for all aspects of teammate management (hiring, training, disciplining, promoting, mentoring, replacing, etc.)
Ensures teammates understand and follow internal procedures and regulatory requirements
Develops and manages department-level budgets (expense and capital)
Approves project and personnel expenses to a given amount level
Provides technical guidance relating to design, manufacturability, process controls, risk management and regulations as needed.
Cultivates and mentors team with an expert understanding of Lean manufacturing and Toyota Production System principles (process capability, product quality, risk management, efficiency, cost reduction, etc.)
Limited travel as required to attend conferences, resolve vendor issues, etc. Travel will vary, but generally will require 1-3 trips per year.
Other duties may be assigned.
Typical experience required is 5+ years as a Manager/Group Leader in Engineering and 10+ years as a practicing Engineer, preferably with experience in both sustaining / manufacturing and new product development / advanced process development roles.
Strong knowledge of FDA Good Manufacturing Practices (GMP) for medical devices and/or combination products, and a thorough understanding of the overall FDA Quality System Regulations (QSR) and ISO 13485.
Strong medical device background is required.
Four-year engineering degree required. An applicable advance degree is preferred (MS or PhD).
Demonstrated capability of creating a culture of continuous improvement, and a track record of accomplishing improvements in quality, cost, and output.
Experience with a variety of manufacturing based technologies preferred (manual vs. automated, polymer and metal processing, packaging, sterilization, etc.)
Experience in structured problem solving and root cause identification with the ability to mentor junior engineers in these techniques.
Proven leadership and personnel development abilities.
Proven project management abilities.
Preferred certifications / experience: Six Sigma, Lean, Toyota Production Systems, Certified Quality Engineer, CAPA and Root Cause methodologies all highly preferred.
Supervisory Duties: Manufacturing Engineering Managers, Group Leaders, Engineers and Technicians
Material and Equipment Directly Used:
Microsoft Word, Excel, Power Point, and Project; and Agile PLM.
Use of Solidworks, Oracle, Minitab, and other software as needed.
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisition Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individuals filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.