Title: Staff Manufacturing Engineer, Fluidics Consumables This position is based in our Campbell, California offices. This position is on-site & full-time
What You'll DoThis position is responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company's Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and, ultimately, scalability for commercialization for Telos' single use fluidics consumable products. This product includes high pressure pumping and priming, and flow control through a complex fluidic and sensor driven architecture. This position may be an individual technical innovation contributor or, as needed, supervise a technical team with responsibility for mentorship and development of other manufacturing engineers, technicians, and/or operators.
- Lead and oversee the manufacturing activities and deliverables for a single use fluidics consumable product.
- Manage in-house and contract manufacturing activities and relationships to ensure single use fluidics consumable products are manufactured in accordance with product plans and quality/regulatory requirements.
- Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
- Develop manufacturing processes and Manufacturing Process Instructions (MPI's) and lot history records (LHR's) or Device History record (DHR's) in collaboration with R&D and Quality.
- Ensure that all single use consumable products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
- Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost-effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company's Quality System requirements
What You'll Bring: - BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ 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 with fluidics systems and subsystems and their interaction and interface with capital hardware and other single use disposables is highly desired
- Experience and knowledge of medical device adhesives and bonding processes across various materials is highly desired
- Previous experience in medical device industry with an emphasis on single use devices and consumables highly preferred
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, bonus, health benefits, generous PTO, and a parental leave program.
Join Us! Apply today.
Salary Range: $150,000 - 167,000 /annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
The posted salary range reflects compensation for employees based in the local Bay Area market. For candidates hired outside of this geographic area, compensation may vary and be adjusted based on location, local market conditions, and other factors
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
