Senior Product Engineer

About the role

The Senior Product Engineer supports the Cytiva Biotech Product Engineering group in the technical aspects of Cassette Product Life Cycle Management (PLCM), including New Product Introduction (NPI), sustainment, and process/product improvements.

Responsibilities

• 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, both internally and externally.
• Manage product changes at the resident site to the current portfolio and 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.

Requirements

• Bachelor’s degree in engineering or equivalent experience with a minimum of 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 exercise judgment based on the analysis of multiple sources of information.

Qualifications

• Ability to travel –
• Valid passport for international travel.

Skills

• Formal training and qualification in Six Sigma techniques and Lean tools.
• Leading cross-functional teams through local and/or global projects.

Benefits

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. These include paid time off, medical/dental/vision insurance, and a 401(k) plan. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please contact: 1-202-419-7762 or applyassistance@danaher.com.