The Senior Product Engineer is responsible for supporting the Cytiva Biotech Product Engineering group in the technical aspects of Cassette Product Life Cycle Management (PLCM), consisting of New Product Introduction (NPI), Sustainment and Process/Product improvements, as required.
This position reports to the Sr Manager, Product Engineering and is part of the Product Engineering team located in Westborough, MA and will be an on-site role.
What you will do:- Introduce new Filtration products by coordinating with R&D, Marketing and Manufacturing in accordance with the Stage Gate Process or Redevelopment of existing products post launch based on volume or other needs.
- Facilitate critical raw material changes while maintaining product quality & customer supply, internally & externally.
- Responsible for managing product changes at resident site to the current portfolio & support products through their lifecycle.
- Manage and execute local manufacturing process transfers or capacity expansions in line with Cytiva procedures.
- Solve problems by using 6 sigma tools, trend analysis, Design of Experiments, FMEA, process risk assessments, etc.
Who you are:- Bachelor's degree in engineering or equivalent experience and minimum 5 years of relevant experience.
- Proficient in risk-based change control activities, assessing product and process changes to ensure compliance, mitigate risk and maintain product quality and supply continuity.
- Minimum 2 years of Validation experience: Medical device or Bio-Pharmaceutical Industry preferred.
- Experience implementing process validation procedures and techniques, such as IQ, OQ & PQ, process and product FMEA, Value Stream Mapping, Ishikawa diagrams, Pareto analysis, parts and process capability studies.
- Generate clear and concise validation documents (Protocols and Reports) for new products, processes and equipment, and Engineering Studies summarizing continuous improvement projects.
- Ability to solve complex problems; take a new perspective on existing solutions and exercises judgement based on the analysis of multiple sources of information.
Travel, Motor Vehicle Record & Physical/Environment Requirements:- Ability to travel -
- Must have a valid passport for international travel.
It would be a plus if you also possess previous experience in:- Formal training and qualification in Six Sigma techniques and Lean tools.
- Leading cross functional teams through local and/or global projects.
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The salary range for this role is $105,000 - $125,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
