The Sr. Device Development and Commercialization Engineer will support end-to-end development of electromechanical devices that interface with disposables, with a focus on infusion pumps that utilize subcutaneous infusion sets and syringes. This role will lead and support design verification and validations activities for infusion pump systems. The role will be the functional SME and technical liaison with internal and external stakeholders. The engineer position within Product Development and Science and Technology will represent the organization in supporting the design, development, analysis and testing of electromechanical hardware/disposables interface.

• Working knowledge of electro-mechanical devices

• Develop and execute design verification plans, and author verification reports

• Conduct effective root cause analysis to investigate issues relating to Electro-Mechanical devices and their interfaces to disposables

• Support the development of system, subsystem and interface design requirements

• Support development and maintenance of traceability among design inputs, design outputs, verifications, and validations. Assists/ supports the identification and implementation of product and process improvement. Develops and or manages infusion pumps system interface traceability matrix.

• Ensures quality and effectiveness of key results of projects within function through sound process design and improvement, early risk assessments, frequent testing supplemented with engineering analysis and implementation of fallback strategies.

• Established strong verbal, written, and interpersonal communication skills with an ability to interface at all levels of the operation environments.

• Participate in design reviews and provide feedback on mechanical designs.

• Ensure compliance with medical device industry standards and regulations.

• Collaborate with internal and external stakeholders in the support of industrialization of consumables in manufacturing.

• Bachelor’s degree in mechanical engineering and (12)+ years of direct mechanical design experience modeling designs in Solid Works.

• A master’s degree in mechanical engineering and (10)+ years of direct mechanical design experience modeling designs in Solid Works.

• (5) + years of experience in the Medical Device, Biotech or Pharmaceutical Industries in relevant device development roles.

• Experience in Solid Works CAD software.

• Strong analytical and problem-solving skills.

• Experience designing products to meet medical device regulations (FDA, EU MDR, etc.)

• Excellent communication and teamwork abilities.

• Experience with tolerance stack-up analyses.

• Experience developing and executing Design Verification testing for medical devices

• Key Stakeholders: Engineering Team • Regulatory Affairs Team • Manufacturing• Quality Assurance

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.