What are the responsibilities and job description for the Product Lifecycle Engineer position at Enterra Medical, Inc.?
Company Overview
Enterra Medical, Inc is dedicated to helping more people with chronic gastroparesis live better lives through advancing technology, bolstering clinical science, and accelerating patient access to Enterra Therapy™. The FDA approved the Humanitarian Device Exemption for Enterra Therapy in 2000. Over 15,000 people have received Enterra Therapy to help resume everyday activities.
Position Summary
The Product Lifecycle Engineer will manage products or systems throughout their lifecycle, from manufacturing to retirement. They will work to ensure that products are reliable, cost-effective, and meet industry standards. They will be working closely with both the internal Enterra team as well as contact manufacturers (CM's) to improve products and ensure supply of products.
Duties And Responsibilities
Enterra Medical, Inc is dedicated to helping more people with chronic gastroparesis live better lives through advancing technology, bolstering clinical science, and accelerating patient access to Enterra Therapy™. The FDA approved the Humanitarian Device Exemption for Enterra Therapy in 2000. Over 15,000 people have received Enterra Therapy to help resume everyday activities.
Position Summary
The Product Lifecycle Engineer will manage products or systems throughout their lifecycle, from manufacturing to retirement. They will work to ensure that products are reliable, cost-effective, and meet industry standards. They will be working closely with both the internal Enterra team as well as contact manufacturers (CM's) to improve products and ensure supply of products.
Duties And Responsibilities
- Work with contract manufacturers to identify and troubleshoot potential product issues
- Drive continuous improvement
- Develop processes for sustaining and improving existing products.
- Work with cross functional teams
- Help identify opportunities for cost and yield improvements
- Schedule regular updates
- Lead product development initiatives
- Work with development on new products to create new manufacturing processes
- Assist in Design for Manufacturing (DFM) activities
- Maintain working relationships with suppliers
- Support regulatory fillings to various government bodies
- Other duties as required
- Bachelor's degree in Engineering or Physics required, Marter's degree preferred
- 5 years experience in medical device product development and new product introduction required
- Experience with class III medical devices preferred
- Ability to work a hybrid/in office weekly with travel up to 20%.
- Knowledge of the requirements as per 21 CFR 820 and ISO 1345/MDR
- Experience with drafting and maintaining DHF and DMR documentations
- Ability to independently develop and adapt work plans based on vague or changing project goals
- Demonstrated ability for independent work.
- Strong hypothesis-driven experimental design and statistical analysis skills
- Ability to communicate effectively orally and in writing
- Ability to travel to meet with customers, suppliers and other stakeholders
- Capability to interact with diverse groups within engineering and maintain strong working relationships with internal and external collaborators
