Medtronic is an Equal Opportunity/Affirmative Action Employer
As a member of the Operations leadership team, participates in defining and executing overall strategic manufacturing and process improvement initiatives that will support business growth while improving standard gross margin of Insulin Delivery products . This Engineering Director will focus on process engineering and serve as the functional leader who will drive technical excellence in engineering process development, process implementation and product cost optimization. The successful candidate will be responsible for building a functional organization that has the capabilities and capacities to meet the business needs. Candidate is responsible for leading a technical organization, linking R&D and manufacturing to ensure successful commercialization of new product initiatives. The candidate will be expected to manage a large group of talented technical professionals, including budget planning, staffing, training, performance evaluation and career development. Hands-on technical leadership and direct experience in launching new products will enable this individual to be a successful role model for the functional organization
The successful candidate will have a demonstrated track record of accomplishments in manufacturing and process development and lead efforts in each of the following areas:
Drive process development activities across multiple projects ensuring engineering solutions are aligned with product development and operations objectives
Implement engineering best practices including appropriate tools and processes
Ensure information flow in a cross-functional matrix teams (internal and external), as appropriate to facilitate work flow, efficiency and quality of work results.
Works cross functionally and maintains customer focus to ensure customer needs are met
Process development for durable medical devices and plastic consumable products
Interact/liaison between multiple departments, organizations, project teams, Medtronic divisions, other companies and suppliers.
Identify and establish departmental objectives and established procedures that are measureable such that outcomes can be quantified.
Actively monitors, both internal and external to Medtronic, for best practices in functional area of responsibility and implements as approved by management.
Determines department organizational structures and implements accordingly. Ensures departmental staff is appropriately trained in current industry technology and company practices and procedures.
Establishes internal engineering practices and standards of work and ensures that all departmental members are trained to those standards.
Prepares and gives or facilitates technical reviews and discussions and presentations to company internal or company external organizations, teams, or individuals.
Prepares and participates in briefings, technical meetings, tactical or strategic planning with other functional areas or upper management. .
Recruits, retains and develops top technical talent
Bachelor’s degree in ME, EE or similar engineering discipline Engineering is required.
YEARS OF EXPERIENCE
10 years of professional technical leadership experience
Minimum of 8+ years’ experience working in technical roles in the design and process development of mechanical, electro-mechanical and/or disposable products.
6+ years of management experience
Understanding of major plastics, metal and electronic component manufacturing processes
Strong people leadership and coaching skills
Understanding of requirements management, configurations management, defect tracking, and requirements tracing
Powerful problem-solving, risk analysis and assessment expected.
Experience with leading and managing development activity across multiple departments in support of enterprise wide projects.
Proven ability to apply situational leadership concepts across various intra and inter-departmental matters.
Strong oral/ written communication skills and interpersonal skills. Demonstrated time management, decision making, presentation and organization skills required.
Experience leading and managing complex, cross-functional projects
Excellent PC skills.
Background in mechanical or electrical engineering principles and methodologies with particular strength in process design and development.
High degree of initiative and self-motivation
Previous experience in a medical device industry.
Advanced degree in appropriate engineering discipline
Familiarity with design for reliability and manufacturing and six-sigma methodology.
Experience with executing projects through the 510k and PMA approval process.
Formal Project management training
Senior management experience in a large corporate or matrixed environment
Familiar with medical product development, design control process, quality and regulatory environments, and the following standards:
o US Good Manufacturing Practices – 21CFR820
o Quality Management – ISO 9001 & 13485
o Risk Management – ISO 14971
o EU Medical Device requirements – Council Directive 93/42/EEC
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Able to lift 10 pounds
Extended periods of time doing computer-based work
Able to travel 20-30%
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...