Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering or Scientific with a minimum of 6 years of manufacturing engineering experience in a highly regulated industry.
• Onsite required.
• Must have ability to travel up to 10%.

Nice To Haves

• Class II and Class III medical device manufacturing experience.
• Advance degree.
• Lean Six Sigma certification.
• Experience with Windchill PTC.
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
• Proven expertise in usage of MS Office Suite.
• Effective communication and project management.
• Strong analytical, problem solving, and technical writing skills.
• Ability to work well independently based on minimal guidance.

Responsibilities

• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Perform other duties and responsibilities as assigned.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.