Job Summary
Responsible for product design and development to attain strategic engineering objectives for the Medline UNITE Foot and Ankle Orthopedics Division. The Senior Product Development Engineer is responsible for design, development, implementation, and ongoing support of implantable foot and ankle products and accessories as well as mentoring junior team members while identifying opportunities to improve department and team performance. The Senior Product Development Engineer will be a subject matter expert and will provide expertise on product design and optimal design specifications. This individual both manages and supports ongoing new product development and legacy engineering projects. The Senior Product Development Engineer identifies critical dimensions and works closely with internal teams and external suppliers to ensure robust component and systems design. Must have proven ability to participate in a team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships and collaboration with peers, customers, and suppliers.Job Description
Plan multiple projects simultaneously and estimate, track, and complete projects on time
Lead multi-disciplinary product development teams to research, design, and develop new products and technologies. Ensure product designs meet all design specifications.
Design and develop single-use and reusable medical instruments, implants, and/or packaging from concept through market introduction. Ensure that designs meet performance specifications, regulatory, and manufacturing requirements.
Generate innovative concepts for new medical device designs to satisfy clinical requirements.
Lead and participate in concept generation activities, including brainstorming sessions.
Manage product development projects and ensure that tasks are completed according to planned timelines. Proactively report project status to personnel
Develop CAD models and drawings of single-use and reusable medical instruments, implants, and/or packaging, including component, subassembly, and top-level drawings applying current ISO, GD&T, and ASME standards.
Work with surgeons, marketing, and sales to define and refine design inputs, generate design concepts and prototypes independently, perform meaningful and timely design evaluations, such as tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs, and oversee generation of documentation of clinical and surgical technique observations to create meaningful design solutions.
Maintain Design History Files (DHFs) per company procedures. Ensure that DHFs are accurate, complete, and well-organized.
Conduct risk analysis activities and complete related forms, including risk plans, DFMEA, risk/benefit assessments, risk reports, and others, for products under development and post-production, as required.
Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods, as required, to plan testing and to analyze test results, and write test reports which draw conclusions from the results.
Ensure that all work satisfies the requirements of the company's QMS, with particular emphasis on design control.
Conduct design reviews as specified in project plans, and in accordance with company procedure.
Provide technical guidance to other team members and mentor junior team members.
REQUIRED EXPERIENCE
Bachelor's degree in Biomedical or Mechanical Engineering or a closely related discipline.
At least 4+ years of product design.
Advanced level skill with SolidWorks modeling software and prototype fabrication.
Advanced level skill with Microsoft Office suite, particularly in Microsoft Excel.
Intermediate level skill with project management software.
Position may require travel up to 10% of the time for business purposes (within US and outside US).
Ability to travel internationally (valid passport).
PREFERRED QUALIFICATIONS
Master's degree in Biomedical or Mechanical Engineering or a closely related discipline.
7-years of medical device product design experience, particularly long-term implants (Class II) and Design for Manufacture (DFM) experience.
Knowledge of FDA QSR's and ISO 13485 design controls, and MDD/MDR (CE Mark) requirements.
Experience with complex mechanical assembly design.
Advanced level skill with project management and project management software.
Recognized on at least one patent filing.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
