Operations Integration Group Leader
- Responsible for organizing, planning, executing, and monitoring all activities required to manufacture, distribute, and service newly developed products.
- Interacts with project manager, design, marketing, clinical, regulatory, and quality core team members to develop user needs including the manufacturing and service requirements.
- Facilitates the inclusion of DFM principles during new product design and development.
- Manages the selection of component suppliers and new product manufacturing sites.
- Manages the manufacturing process development and implementation at the chosen manufacturing facility.
- Develops COGS, manufacturing, distribution, and servicing cost analyses related to newly developed products.
- Develops project plans and tracks progress related to the above listed initiatives.
- Conforms to, supports and enforces all Company policies and procedures
- Participates in any and all reasonable work activities as deemed appropriate and assigned by management.
Position Qualification Requirements
- Bachelors degree in Engineering; Mechanical, Electrical, Chemical or related field
- At least (5) years experience in a discipline such as or related to a Project Engineer, Sr. Product/Manufacturing Engineer, or Engineering Department Group Leader
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
- Masters degree in engineering/business field or a Professional Engineering License
- Experience in new product development
- Experience in manufacturing process design and validation
- Experience in a regulated industry
- Advanced Microsoft application skills to include Word, Excel, PowerPoint, and Project.
- Ability to apply a broad range of expertise of principles, practices and procedures of particular function to technology related issues.
- Ability to work with multiple functional departments making key technical contributions affecting the direction of the group and projects.
- Effective project management experience: minimum four years.
- Effective lead manufacturing or operations experience: minimum five years.
- Experience in regulated design environments - specifically medical device development, FDA or ISO registered work experience desirable.
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
- Must have excellent verbal and written communication skills to facilitate required problem-solving communications with internal departments, teams, external customers and suppliers.
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.