Technical Lead, Medical Device Prototyping & Development

AbbVie Inc.; Tempe (AZ); Hybrid; USD 170,000 - 210,000; Full time

Job summary

AbbVie is seeking a Technical Lead, Product Development to provide technical leadership for medical-device and combination-product prototyping and feasibility activities. You will apply expertise across mechanical, plastics, electrical, software, HF, and usability engineering to develop integrated product solutions.

Responsibilities include leading cross-functional teams, guiding design decisions for design controls, verification, and regulatory submissions, and ensuring alignment with ISO 14971

Qualifications

• 14+ years of experience in a science/engineering field.
• Ability to lead prototyping and feasibility studies.
• Experience with design controls and regulatory considerations.
• Strong communication and cross-functional collaboration.
• Publications or patents may be noted.

Responsibilities

• Lead prototyping and feasibility activities for medical-device programs.
• Develop and evaluate product concepts, prototypes, designs, and technical solutions.
• Apply expertise in mechanical and electrical design, software, and human factors.
• Collaborate with quality, regulatory, and manufacturing partners.
• Support the development, integration, and testing of hardware and device software.
• Lead cross-functional technical discussions and influence decisions.

Skills

Technical leadership

Prototyping

DFM/DFx

Design controls

Regulatory submissions

Education

BS or equivalent

MS/PhD preferred

Job description

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The TechnicalLead, Product Development provides technical leadership for medical-device and combination-product prototyping and feasibility activities. This role applies expertise in mechanical, plastic, electrical, software, human factors, and usability engineering to develop integrated product solutions. The Technical Lead resolves technical challenges, influences cross-functional decisions, and considers the impact of development activities on design controls, verification and validation, risk management, and regulatory submissions.

Responsibilities

• Lead prototyping and feasibility activities for medical-device and combination-product programs.
• Develop and evaluate product concepts, prototypes, designs, and technical solutions.
• Apply expertise in mechanical and plastic-part design, injection molding, DFM, DFA,DFx, and tolerance analysis.
• Collaborate with electrical, software, systems, human factors, quality, regulatory, and manufacturing partners.
• Support the development, integration, and testing of electrical hardware and device software.
• Resolve technical challenges and design tradeoffs using engineering judgment and data analysis.
• Plan, execute, analyze, and document feasibility studies and prototype evaluations.
• Apply knowledge of design controls, ISO 14971, ISO 13485, DHF documentation, and design verification and validation.
• Assess how technical decisions and design changes may affect product requirements and regulatory submissions.
• Lead cross-functional technical discussions and influence decisions without direct authority.

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies.
• Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
• Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
• Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
• Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability ofanybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html