Sr. Product Development Engineer

BioSpace; Branchburg Township (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Job summary

A global biopharmaceutical company in New Jersey seeks a Senior Engineer to design and develop medical devices. This role involves identifying best practices, developing strategies for efficient product development, and collaborating across teams. Ideal candidates have a Bachelor's degree with extensive product development experience and strong problem-solving skills. A competitive salary and comprehensive benefits package are offered.

Qualifications

• 8+ years of Product Development experience with a Bachelor's Degree.
• Experience in a regulated environment.
• Experience with business stage gate processes is preferred.

Responsibilities

• Identify best practices and strategies for product development.
• Develop methodologies to mitigate project risk.
• Provide technical expertise for product requirements.
• May participate in ethnographic studies to support the development of User Needs, including identification of user groups, definition of surgical techniques and user-product interface, and exploration of new applications.
• Provides technical expertise in establishing approach to defining product requirements / design inputs, designing product, developing appropriate test methods, analyzing data and resolving complex design problems associated with product performance.
• Partners closely with cross-functional partners to understand internal expectations and requirements for development and makes recommendations for shifts in R&D strategy to accommodate as necessary.
• Supports project teams through creation of design & development deliverables (e.g. control strategies, bridging strategies) to facilitate transfer of knowledge and ensure successful designs and design for manufacturability.
• Facilitate brainstorming/troubleshooting sessions to solve complex design challenges.

Skills

Critical thinking and problem solving skills

Ability to manage diverse projects

Self-motivated

Strong communication skills

Statistical analysis

Team leadership experience

Risk management

Quality by design

Design for manufacturability

Education

Bachelors Degree in engineering or related field

Master's degree in engineering or related field

PhD in engineering or related field

Tools

Minitab

Solidworks

Job description

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Job Description

Develops and implements tools, best practices and strategies to enable robust and efficient design and development of medical devices and combination products, with a heightened focus on early-stage development.

• Under general direction, the Senior Engineer will identify and prioritize various aspects of development to optimize based on the needs of the organization.
• Once identified as a priority, the Senior Engineer will conduct research to benchmark best practices where possible.
• The Senior Engineer will then lead efforts to develop, refine, gain alignment and implement best practices, strategies and associated tools, collaborating cross-functionally as necessary.

Responsibilities

• Building Development Excellence: Identifies best practices, strategies and tools for product development to enable robust and efficient execution of design control and related aspects of product development.
• Develops and implements new methodologies and tools to facilitate good design & development practices, ensure timely decisions and mitigate project risk across various device types (e.g. combination products, tissue-based devices, injectable devices, capital equipment, 510(k) devices, PMA devices, etc.), including ideation and early research prior to initiation of design control.
• Initial focus is on various aspects of early-stage development (e.g. understanding relevant disease states, developing design inputs, executing design & process characterization studies, establishing design outputs, etc.).
• May participate in ethnographic studies to support the development of User Needs, including identification of user groups, definition of surgical techniques and user-product interface, and exploration of new applications.
• Provides technical expertise in establishing approach to defining product requirements / design inputs, designing product, developing appropriate test methods, analyzing data and resolving complex design problems associated with product performance.
• Partners closely with cross-functional partners to understand internal expectations and requirements for development and makes recommendations for shifts in R&D strategy to accommodate as necessary.
• Supports project teams through creation of design & development deliverables (e.g. control strategies, bridging strategies) to facilitate transfer of knowledge and ensure successful designs and design for manufacturability.
• Facilitate brainstorming/troubleshooting sessions to solve complex design challenges.

Additional Responsibilities

• Develops training materials and facilitates training sessions for project teams on newly created best practices and associated tools.
• Periodically engages with project teams post-training, as necessary, to assess adoption and effectiveness of tools and best practices.
• Maintain ongoing connection with project teams to uncover opportunities for continuous improvement. Engage with Design Control Solutions Team to ensure alignment of efforts.

Qualifications

Education and Experience

• Bachelors Degree in engineering or related field with 8+ years Product Development experience, or Masters degree with 6+ years Product Development experience, or PhD with 4+ years Product Development experience
• Medical device experience or experience in a regulated environment
• Experience developing products within a business stage gate process (preferred)

Other Professional Skills

• Demonstrated critical thinking and problem solving skills
• Ability to exercise judgment both within defined procedures and policies and balanced across technical and business needs
• Ability to manage diverse, simultaneous projects of varying complexities
• Self-motivated; ability to execute under minimal supervision
• Identifies, understands and proactively mitigates technical/product risk
• Ability to communicate highly technical information in a clear and easy-to-understand way (both verbally and in writing)
• Demonstrated strong business acumen
• Experience in identifying and executing continuous improvement initiatives
• Team leadership experience
• Applied experience with statistical analysis; experience using Minitab preferred
• Demonstrated understanding of advanced engineering principles and practices
• Design Control knowledge and thorough understanding of medical device standards and regulations
• Demonstrated understanding of existing development methodologies (e.g. design excellence, design for manufacturability, quality by design) and ability to distill complex experiment design into manageable studies.
• Product development experience
• Experience using Computer-Aided Design (CAD) programs; Solidworks preferred

Other Information

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

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