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Sr Sustaining Engineer

3 months ago

St Paul, United States Vital Path Full time
Join VitalPath in Maplewood as a Sr Sustaining Engineer

About VitalPath

VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We're excited about this important work and bring vital energy to our customer partnerships. In our growing organization it's important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people's lives and be a part of a friendly, fun place to work with people that value diversity, come join our team

About the Position

Sr. Sustaining Engineer leads initiatives for the daily support of products, processes, materials, and equipment and is responsible for leading integration of new products within production, meeting new product integration timelines and production goals (i.e.: safety, quality, cost, delivery and productivity) This person is required to partner with cross functional teams to evaluate, troubleshoot, and implement manufacturing processes to ensure we produce high quality product at a low cost. You will be responsible for the support and troubleshooting of the entire scope of the manufacturing process and direct participation in managing CIs, quality issues investigations NMRs to ensure full compliance to FDA QSR and applicable ISO 13485 requirements. Perform work in adherence to the VitalPath Quality Management System (QMS), including development and maintenance of documentation.

Responsibilities
  • Work in a cross-functional environment cooperatively with Process development, R&D, Production, Quality, Supply Chain, etc. on complex projects to ensure success to deliver customers' requirements of time delivery and quoted price
  • Consistently generates innovative and unique solutions to complex problems of diverse scope to meet department goals.
  • Support the troubleshooting of equipment and manufacturing processes
  • Ability to work well under pressure
  • Designing, planning and analyzing different aspects of the production methods to eliminate waste and create a user-friendly manufacturing process
  • Ensures that new products introduced to the production floor meet business, quality, output and cost goals and objectives
  • Designs and coordinates applicable engineering tests and experiments. Summarizes, analyzes, and draws conclusions from complex test results.
  • Designs and prepares engineering reports and communicates results to the technical and leadership audiences.
  • Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
  • Leads in the identification, implementation, and management of Business Unit goals and actively contributes to development of Business Unit's multi-year strategy.
  • Capable of training team members, including engineers, technicians, and product builders on specific tasks. Participates in the development of junior staff by setting an example, providing guidance, and offering counsel.
  • Develop bills of materials (BOM) and method of manufacture (MOM), update work instructions and provide any needed training to technicians and assemblers related to processes and equipment
  • Create tooling and fixtures to improve the manufacturing processes and ease the operator's job in the assembly area
  • Assist in training Product Builders to processes associated with the design and manufacture of medical catheters
  • Support and execute CI projects to reduce the cost and improve yields in the production area
Requirements
  • 5+ years in a medical device manufacturing environment, with exposure to product design and fixture design
  • Experience solving advanced technical problems
  • Experience qualifying complex equipment
  • Experience in the implementation of Lean manufacturing principles
  • Experience managing multiple projects simultaneously
  • Strong bias for action and ability to effectively prioritize work and deliver business results in a fast-paced, constantly changing environment are critical
  • Practical understanding of manufacturing problem solving and process improvement tools such as DMAIC and production flow tools such as LEAN manufacturing
  • Demonstrated excellent written and oral communication skills
Preferred
  • CAD or SolidWorks experience
  • Experience with design controls, FDA regulation, GMP practices, and QSR requirements
Benefits
  • Comprehensive, Low Cost Health and Dental Insurance Plans Available
  • Vision Insurance
  • Health Savings Account with company contribution
  • Short and Long Term Disability
  • Supplemental insurances (short term disability, AD&D, life insurance, and more)
  • Paid Time Off
  • Sick Time Off
  • Paid Holidays
  • 401K with company match
  • Competitive compensation
  • Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.