Senior/Principal Medical Device Engineer

Ventura Solutions is a trusted Medical Device and combination products consulting, staffing, and training firm. We believe that the best way to advance healthcare is through innovation and continuous improvement. We value our commitment to solving healthcare's toughest problems and delivering world-class products, services, and human resource solutions. We are a company of problem solvers, inventors, teachers, and friends.

Our company offers an energized, collaborative, optimistic, and fun culture that cultivates an inventive spirit while being committed to exceeding client expectations. We offer opportunities for career growth, fulfilling projects, excellent salaries, competitive benefits, flexible hours, along with many work from home/remote opportunities. For more information about us visit us at www.ventura-solutions.com

Are You an Exceptional (Senior/Principal) Medical Device Engineer looking for a new opportunity with an innovative and growing Medical Device consulting firm?

We are seeking Senior and Principal-level Medical Device Engineers who are enthusiastic about applying their expertise in a challenging and rewarding consultancy role!

Experience and passion are what we desire for this role and we're looking for the best! While working in this role you will have the ability to:

Create Design History File (DHF) specifications and ensure 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 Medical Device Engineer on our team, you will utilize your engineering, technical, and research skills to drive the development of innovative new Medical Devices and combination products, as well as the remediation and maintenance of existing product lines. This role involves creating, managing, and analyzing Design History File (DHF) specifications, product risk management files, and other associated engineering design files, to ensure excellence in design and functionality. 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 3+ 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, maintaining, and remediating Design History Files (DHFs) and ensuring compliance to CFR 820.30 Design Controls, ISO 13485, and ISO 14971 Risk Management.
• Medical Device and/or Combination Product Experience.
• Basic understanding of engineering principles, system design, traceability, design controls 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 Qualifications, but not required

• 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.
• Experience with software as a Medical Device (SaMD) or digital health.
• 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.
• Experience with Project Management, Gantt Charts, PMP.
• Experience with electromechanical, electrical, or software.

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.

If you can say YES to the above requirements, we want to talk to you – APPLY NOW! We would love to talk about your experience, career goals, and fit with this amazing role.

Location

• Remote

Employee Type

• W2 Employee
• Open to 1099 engagements

Benefits

• Choice of medical dental and vision plans
• Paid Vacation Time
• Competitive base salary
• 401(k)

This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW!

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