Job Description

The Principal Supplier Engineer will apply knowledge of good manufacturing practices, process knowledge and quality engineering principles and methods to ensure compliance with regulatory requirements. Additionally, the supplier development process engineer will develop supplier management systems and ensure compliance to procedures to initiate and optimize process development, qualify, and stabilize new component supply chain, device manufacturing, and device distribution.

This exciting opportunity will support a differentiated business as it is spun out of Edwards Lifesciences and is established as a new independent medical device company, enableCV. This role will assist in the transition from Edwards to enableCV while supporting active programs in commercial production and new product introduction. enableCV is based in Midvale, UT and this role will be located on site at the enableCV headquarters. This is a flexible on-site role which will thrive in a collaborative, start up like environment.

Key Responsibilities:

• Establish effective and productive relationships with contract manufacturing partners and technical staff. Act as the liaison between enableCV and the contract manufacturers for all product and process related changes.
• Plan and direct complex project activities (e.g. value engineering, product engineering, process engineering, advanced engineering) with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business.
• Develop project plans, schedule, scope, and quality objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups and key stakeholders.
• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files.

Required Qualifications:

• Bachelor's Degree in an Engineering or Scientific field with at least 8 years of previous related work experience, including either industry or industry/education

Preferred Qualifications:

• Experience working in the medical device industry
• Proven ability to manage projects
• Experience working with suppliers and full service contract manufacturing organizations, including packaging and sterilization
• Experience reporting to leadership, doing presentations, and managing timelines
• Data analytics experience, including creating dashboards to track multiple in-flight programs
• Proven expertise in usage of MS Office Suite
• Proven skill in statistical techniques including study design and data analysis
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Knowledge of Six Sigma concepts, including DMAIC
• Knowledge of Manufacturing and Quality Engineering concepts
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in catheter manufacturing
• Strict attention to detail
• Ability to manage competing priorities in a fast paced environment
• Experience representing an organization in providing solutions to difficult technical issues associated with specific projects
• Ability to resolve complex problems or problems where precedent may not exist

Job Tags

Similar Jobs