Title: Supplier Quality Engineer

Type of Hire: Direct Hire

Location : Lakewood, CO

Relocation: Yes

Job Description:

We are currently seeking qualified candidates for the position of Supplier Quality Engineer III, which is responsible for working collaboratively with Suppliers and R&D on both new product development and improvements to existing product quality. This individual will work cross functionally to incorporate design for manufacturing/assembly, perform tolerance analysis, development & validate manufacturing processes, provide tool design input, develop measurement systems and select qualified suppliers. Position will have a focus on process development, validation, component / device quality, Quality plans, tool design and equipment requirements related to manufacturing processes for medical devices. Seeking candidates with excellent technical skills and communication skills.

Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Responsible for driving quality through design by working cross functionally with R&D and suppliers on component and device designs.
• Responsible for improving the quality of existing products sourced through external manufacturing suppliers (CMOs) and Distributed products.
• Responsible for establishing relationship with key suppliers and acts as Point of Contact for technical issues and concerns during product development.
• Operates independently on key projects representing Supplier Quality Function. Provide guidance and mentorship to junior members of team on the principles of supplier management, new product design, and component qualification.
• Conducts product design reviews with suppliers to solicit manufacturing, dimensioning, and test input.
• Qualifies manufacturing processes and performs test method validations in collaboration with suppliers.
• Develops supplier requirements and performs assessment of suppliers for selection of new suppliers.
• Review and approve product specifications and requirements.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Advises team members pro-actively on technical ideas and promotes skill development of team work.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Work direction responsibility may include technicians and junior engineers.
• Works with R&D, manufacturing and other functional groups on design, manufacturing, and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering. Mechanical, Industrial, or Biomedical preferred.
• Masters of Science Degree in Engineering, optional.

Experience

• Minimum 6 years experience, with medical device experience preferred.
• Two years of GMP manufacturing experience required.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
• Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Strong technical problem solving skills.
• Mechanical and electronic ability aptitude to assist with equipment trouble-shooting.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.