Job Description

We are seeking a Senior Engineer that will utilize their engineering/technical skills and experience to drive the development and maintenance of combination products and medical devices. This position will involve creating Design History File (DHF) specifications and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management. The engineer will collaborate with other functional team members on researching requirements, driving design verification and validation, and human factors, along with owning all the DHF and risk management deliverables to ensure the safety and efficacy of new and existing products.

Responsibilities

As a Senior Engineer, you will utilize your engineering and research skills to drive innovative new product development and remediate and maintain existing product lines by creating, managing, and analyzing DHF specifications, product risk management files, and other associated engineering design files. Specifically, depending on the project assignment you will:

• Participate in focus groups and in early use case development to identify unmet needs for design & engineering concept development.
• Work with marketing teams to clearly define unmet needs and User Needs for upstream product development efforts.
• Lead the development of Design History Files (DHF) and Risk Management Files.
• Research device clinical use, standards, and other relevant regulatory guidance documents to support new product development and regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and ISO 14971 Risk Management for medical devices and/or combination products.
• Research industry best practices and define state-of-the-art for new and existing products.
• Analyze product complaints and standards to create robust design inputs and user needs
• Partner with other functions including Manufacturing, Safety/Clinical, Human Factors, Quality, Regulatory, and Design Engineering to lead and perform risk assessments.
• Develop FMEAs to ensure failure modes and patient risks are identified & mitigated; lead risk management activities; provide risk and design control input to cross-functional teams.
• Supports medical device and combination product inspection readiness and regulatory responses as needed.
• Support the completion of gap assessments against industry regulations or standards.
• Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, and inspection readiness.
• Lead design verification and validation.

Qualifications

• Bachelor's degree in engineering with 5+ years of experience in developing medical devices, drug delivery devices, and/or combination products.
• An Engineering degree in Biomedical, Mechanical, Chemical, or Industrial engineering is a great fit, but other engineering degrees will be considered.
• Experience creating and maintaining Design History Files (DHF) and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management.
• Medical Device and/or Combination Product Experience.
• Basic understanding of engineering principles, system design, traceability, and risk management.
• Experienced with performing risk assessments using a variety of tools.
• Experience leading other engineering disciplines to execute and able to support product development technical challenges.
• Experience with design verification and validation.
• Experience with change control and design transfer.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues.
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgment.

Preferred, but not required, Qualifications

• Master’s degree preferred but not required.
• Strong statistical analysis skills, Design of experiments (DOE), Minitab.
• EU and MDR experience with medical devices or combination products.
• Extensive experience in risk management and design control of medical devices or combination products from concept through launch.
• Experience or familiarity with drug product development practices required for clinical trials and commercial products.
• Have experience working with third-party development partners.
• Experience with Mechanical, single-use disposable, or re-usable products.
• Understanding of recognized consensus standards for single-use combination products related to but not limited to biocompatibility, particulate, sterility etc.
• Experience with human factors engineering. Creation of use error risk analysis reports, usability assessments, human factors plans, and human factors reports.
• Experience with prefilled syringes or autoinjectors.
• A combination of strong pharmaceutical, combination products, and medical device development experience is preferred.
• Experience with the ISO-11608 series of standards.
• Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971/24971, and 21 CFR 820.

Key Leadership Competencies

• Strong Communication Skills.
• Builds strong relationships with peers and cross-functionally with partners to enable higher performance.
• Strong leadership, negotiation, interpersonal, communication, and facilitation skills.
• Learns fast, grasps the "essence" and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Proven ability to succeed in a fast-paced, challenging, and complex environment.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
• Strong interpersonal and communication skills with demonstrated ability to work within a team environment.

Location

• Illinois is preferred but open to remote (US)

Employee Type

• W2 Employee

Benefits

• Choice of medical dental and vision plans
• Paid Vacation Time
• Competitive base salary

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled