Pall is a Fortune 1000 materials science and engineering company with the broadest filtration, separation and purification capabilities in the world. Our process and product enabling technologies help our customers make good products better, safer and even possible. We provide innovative products to customers in health care, biotechnology, pharmaceutical, semiconductor, municipal drinking water, aerospace and industrial manufacturing markets. Headquartered in Long Island, NY, Pall has operations in every major country
Pall is currently seeking an experienced Product Development- “Senior Engineer.” This exciting position will support the Biopharm Business unit working as a part of the Tangential Flow Filtration (TFF) R&D team to provide new technologies and products into this growing market. The position is located in our North East Center of Excellence (NECOE) located Westborough, Massachusetts and will interact with various groups co located in the NECOE, as well as functional groups based out of NY, Europe, and Asia.
The R+D Senior Engineer will report to the R+D Director in Westborough.
Responsibilities include:
- Work closely as part of a cross functional team to develop new and innovative product designs and technology enhancements for TFF applications.
- Understand the practical conditions of use for new products and develop a thorough understanding of the target market requirements and specifications.
- Assist in developing product performance requirements and verification test plans.
- Produce functional prototypes, test their performance, and prepare formal assessment reports of that performance.
- Review and update Risk Analysis/FMEA to ensure that Test Plan reflects all possible scenarios.
- Transfer design to manufacturing - develop component and product assembly drawings, bills of materials and interface with Manufacturing Engineering and Engineering Management on assembly procedures.
- Co-ordinate where necessary with contract engineering, design, and manufacturing services.
- Understand and adhere to the Pall development process for conformance to ISO and cGMP standards.
- Maintain Design Files for the development process per ISO requirements.
- Contribute engineering input for validation and product introduction plans. Monitor design performance in product validations.
- Create design history documentation for development files and summarize critical design factors for reference by design authorities.
- Comply with all regulatory requirements of the market for the development process and contribute to the design as necessary to insure the product itself fulfills all regulatory requirements.
- Provide technical support for newly released products in the field
- Assist in the analysis of product performance issues on products either newly launched or established in particular application areas. Demonstrated skills and experience in technical project management.
- Demonstrated ability to work with and across multiple functional groups in order to meet project requirements
- Become familiar with and comply with all company policies and procedures.
Required Qualifications:
- Minimum BS degree in an Engineering discipline.
Mechanical engineering preferred.
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5-10 years of experience in New Product Development including:
- User need definition and translation into product specifications
- Risk assessment and mitigation plans
- Feasibility testing and edge of failure analysis
- Verification and validation testing
- Process validation and transfer to manufacturing
Preferred:
- Familiarity with manufacturing processes such as plastic injection molding, ultrasonic welding, hot plate welding, and plastic material properties strongly preferred.
- Knowledge of statistical data evaluation, DOE’s, Six sigma, etc preferred.
- Expertise in computer use including CAD, spreadsheets, word processing, project planning, and presentation software.
- Experience in medical device, pharmaceutical testing, food service, automotive, or similarly regulated industry strongly preferred
The above describes the essential content of and requirements for proficient performance in the position and is not meant to be all-inclusive.
Pall Corporation is an Equal Opportunity Employer who encourages diversity in the workplace. All qualified applicants will receive consideration for employment without regard to gender, race, color, national origin, ancestry, citizenship, religion, age, physical or mental disability, medical condition, sexual orientation, gender identity or gender expression, military or protected veteran status or marital status.
