Senior Product Engineer

Cytiva; Westborough (MA); On-site; USD 105,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) to eligible employees

Bonus/incentive pay

Job summary

Cytiva in Westborough, MA seeks a Senior Product Engineer to support PLCM through NPI, sustainment, and process improvements, reporting to the Sr Manager, Product Engineering, in an on-site role.

You will collaborate with R&D, Marketing, and Manufacturing, lead product changes, and drive validation activities using IQ/OQ/PQ and Six Sigma tools to ensure quality and supply continuity.

Qualifications

• Bachelor's degree in engineering or equivalent experience; 5+ years relevant experience.
• Experience with risk-based change control activities.
• Minimum 2 years of Validation experience: Medical device or Bio-Pharmaceutical Industry preferred.
• Experience implementing validation procedures and techniques: IQ, OQ & PQ, FMEA, Value Stream Mapping, Ishikawa diagrams, Pareto analysis.
• 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.

Responsibilities

• Introduce new Filtration products by coordinating with R&D, Marketing and Manufacturing.
• Facilitate critical raw material changes while maintaining product quality & customer supply.
• 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.

Skills

Change control

Validation experience

Six Sigma

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ validation

FMEA

Value Stream Mapping

Ishikawa diagrams

Pareto analysis

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

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 – <10% travel, overnight, international, and within territory or locations.
• 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.

• paid time off
• medical/dental/vision insurance
• 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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].