Shire Senior Test Engineer - Devices in Lexington, Massachusetts

Summary:

The Sr. Test Engineer will support device development teams with general device testing and related test development activities. Areas of focus will include protocol and report writing, prototype development, test development, fixture development, testing and overall lab maintenance.

Responsibilities (% of time):

  • Create test procedures, test protocols, and execute testing per direction from Device Development team. Set up and operate test equipment and record results. Maintain accurate data and support analysis. – 50%

  • Assist in concept generation, design, development, and evaluation of new products, materials and technologies. Provide input to design of fixtures, tooling, equipment and specifications. – 25%

  • Support overall test laboratory activities including, but not limited to, test development, gage R&R studies, fabrication of prototypes, coordination of testing and calibration/PM of test equipment -15%

  • Establish and foster strong collaborative relationships with external test equipment development / testing partners and service providers. - 5%

  • Assist in deviation, complaint, and failure investigations. 5%

Requirements:

  • A Bachelor’s of Science Degree in Engineering required

  • Minimum 5 years’ experience in the field of medical device and/or combination product testing

  • Prior experience in collaboration with external partner a plus

  • Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..) a plus

  • Experience in test method qualification and validation

Notice to Employment / Recruitment Agents:

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Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.