Senior Manufacturing Engineer
4 weeks ago
We are seeking a highly skilled Senior Manufacturing Engineer to join our team at Telos Health, Inc. in Campbell, California. As a key member of our manufacturing team, you will be responsible for ensuring the timely and cost-effective manufacture of our products, while maintaining the highest level of quality and regulatory compliance.
Key Responsibilities- Establish and manage in-house and/or contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
- Develop manufacturing processes and Manufacturing Process Instructions (MPI's) and lot history records (LHR's) in collaboration with R&D and Quality.
- Lead the construction of prototypes for new products/processes or current product enhancements, and perform time studies for each manufacturing process and identify process development initiatives.
- Provide oversight and coordinate multi-functional operations project team activities from early project conceptualization through clinical testing.
- Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
- Determine tooling and equipment needs for the timely and cost-effective manufacture of products.
- BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
- Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
- Familiar with GMP, GDP procedures and requirements.
- Must be able to travel.
- Excellent communications skills (both written and verbal) required.
- Ability to work independently or in team setting required.
- Project management experience preferred.
As a valued member of our team, you will receive a competitive salary, stock options, a 401k plan, health benefits, generous PTO, and a parental leave program.
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