SUMMARY OF POSITION
As a member of the manufacturing and product development team, the individual works closely with the design engineering, product development and manufacturing teams to meet new product release objectives and to support existing product lines with continuous improvement in mind.
- Ensure that new products are released on schedule with robust processes and acceptance testing methodologies that achieve cost objectives.
- Support the installation and maintenance of equipment in the production area.
- Achieve 3 sigma or better quality performance and support the sales plan with upside potential.
- Is the manufacturing technical expert to the design and analysis team to ensure manufacturability of product throughout the design and development process and with key supplier partners.
- Create and executes manufacturing plans, with layouts that are efficient, and flexible.
- Writes detailed manufacturing process development protocols (IQ, OQ, PQ) that document and control processes that meet product requirements.
- Specify manufacturing tools and equipment.
- Design necessary fixtures and tooling required to manufacture, assemble and inspect products at component and final assembly.
- Leads cross-functional teams as a project manager and achieves project objectives. Will also participate on cross functional teams as a team member.
- Supports existing products with problem solving and continuous improvement of cost and quality objectives.
- Writes detailed manufacturing procedures that document and control processes that meet product requirements.
- Trains the manufacturing team on new product methods and changes to existing product procedures.
- Implement process and product changes using existing change control process.
Education and Experience
- BS degree in Electrical, Mechanical, or Manufacturing Engineering
- Minimum of 5-7 years of experience in the assembly of electronics, hydraulics, and mechanical products. Medical device experience is preferred.
- Experience in Project Management with the ability to lead a cross functional team.
- Experience with process validation, establishing acceptance tests and criteria in association with new product development.
- Experience developing manufacturing fixtures and tooling
- Experience with process flow mapping, lean manufacturing, and six sigma.
- Experience working in an ISO 9001 / ISO 13485 environment.
- Experience in meeting new product cost of goods objectives and life cycle cost improvements.
ESSENTIAL KNOWLEDGE, SKILLS
- Strong commitment to team and working together to achieve goals
- Strong interpersonal skills
- A self-starter with a strong passion for growth and learning
- Results oriented, works independently and manages multiple projects simultaneously.
- Excellent technical writing and report writing abilities.
- Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences.
- Excellent planning, organizational, and project management skills
- Ability to meet challenging milestones
- Ability to work effectively within a fast-paced, changing environment.
- Ability to problem solve independently and with others.
- Ability to influence others without direct reporting relationships.
- Strong attention to detail and commitment to quality work
- Strong computer skills, Microsoft Office
- Basic knowledge of Solidworks or other 3D CAD software preferred
Travel % (if applicable): Less than 5% if at all.
Freedom Innovations offers competitive compensation and a generous benefit package including a 401(k) with company match. EOE