Senior Hardware-Software Device Engineer I or II, Combination Product Development, R&D

ZipRecruiter; North Chicago (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Device Engineer to join their innovative team focused on developing cutting-edge drug/device combination products. This role involves collaborating with cross-functional teams to ensure the successful transition of products from concept to commercialization. You will engage in feasibility assessments, design verification, and compliance with regulatory standards, all while addressing complex health challenges. If you are passionate about engineering and biopharmaceuticals and thrive in a dynamic environment, this opportunity offers the chance to make a significant impact on people's lives through your work.

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Short-term Incentive Programs

Long-term Incentive Programs

Qualifications

• 8+ years of experience in device development, especially in regulated industries.
• Strong understanding of Design Controls and Medical Device Software Lifecycle.

Responsibilities

• Conduct feasibility assessments and develop user interface requirements.
• Support design verification and compliance with international standards.

Skills

Device Development

Software Engineering

Electrical Engineering

Communication Skills

Analytical Skills

Multitasking

Education

BS in Software Engineering

MS in Biomedical Engineering

Tools

Prototyping Tools

Automated Testing Tools

Statistical Analysis Software

Job description

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

We are looking for a Senior Device Engineer who has experience in development of electromechanical devices/combination products primarily with a Software Engineering or Electrical Engineering background to join our Device Engineering team in Combination Product Development, R&D. This individual will contribute to the development of exciting new drug/device combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development.

Within Combination Product Development, the Product Engineering team is responsible for developing products informed by user needs and product requirements, completing feasibility assessments (including prototyping and lab testing), and ultimately supporting design and verification activities that result in safe and effective devices. These devices enable the delivery of AbbVie’s innovative medicines across a broad range of therapeutic areas and routes of administration; the resulting combination products target difficult-to-treat diseases with the goal of making a remarkable impact on people’s lives.

You would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. The problems you would help to solve relate not only to the function of innovative electromechanical devices, but also the way in which they interact with drug products and the human body. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of developing solutions to tough health challenges, this opportunity might be for you.

This position is based in Lake County, IL, US.

Responsibilities:

• Feasibility assessments, including prototyping, analysis, and lab testing
• Definition and execution of engineering confidence test plans and design margin assessment
• Development of User Interface and translation of user workflow to software requirements
• Ability to understand software and hardware architectures, modules, and interfaces
• Understand and support system reliability studies from electrical hardware perspective (e.g. battery life, power budget over service life, etc.)
• Planning for Design outputs and ownership of Design Output Reviews
• Design Verification support including design and execution of tests using automated tests tools and manual test development (test method development, issue resolution)
• Assisting the development team in troubleshooting and solving issues, including developing hardware and software tools to advance root cause investigations
• Assessment of compliance to international standards and regulatory requirements for software and medical devices including cybersecurity; support documentation to ensure compliance
• Collaborating with external global manufacturing and development partners
• This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.
• Contribute to raising the bar on how we develop combination products. This includes the identification and leadership of improvement initiatives, generating new ideas and connecting unrelated concepts to spark innovation for our products and processes.
• Some travel required

Qualifications:

• BS in Software Engineering, Computer Science, Electrical Engineering, or Biomedical Engineering with 8+ years of experience or MS with 6+ years of experience (MS)
• Experience must include significant device development, with medical device, pharmaceutical or other regulated industries
• Experience developing software for a range of electromechanical or medical devices, preferably in the drug delivery space
• Familiarity with electrical schematics and system design
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO 14971)
• Strong communication skills (both written and verbal) including the ability to influence without direct authority
• Strong device design and analytical skills
• Proficiency in tolerance analysis and descriptive statistics
• Ability to create and manage schedules for sub-tasks and work streams for which you are responsible
• A keen eye for identifying project goals and risks, and proactively developing implementation and mitigation plans
• Ability to multitask and work within timelines.

Additional Information:

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

Position will be hired based on level of experience.

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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, sex, national origin, age, disability (including physical or mental), medical condition, genetic information, or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://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