Product Development Engineer (Pde)

Product Development Engineer (PDE)

Date: Mar. 1, 2024

Job Location: San Fernando, CA 91340

Position Type: Full Time

Job Shift: Day (On-site)

Travel: Up to 10%

Medicus Surgical LLC (Medicus) is an emerging medical device company providing new/innovative Product Development for orthopedics solutions. Medicus is built on the core principles that drive innovation and quality. Medicus is actively searching for a Product Development Engineer (PDE), who will be responsible for leading projects for full life cycle development of orthopedic devices. This includes initiation, design, development, and execution phases.

The ideal candidate will have a minimum of 2-3 years of work experience in design and development of medical devices/implants (plates, screws, instruments, tools, etc.). Along with strong Biomedical and Mechanical engineering experience, excellent interpersonal skills are required for the position.

Essential Duties and Responsibilities:

• As a PDE, produce deliverables from idea generation to commercialization through entire product life cycle phases and within schedule, as directed, including:

o Design components/systems and modify existing designs to develop or improve products and facilitate manufacturing operations.

o Prepare 3D models of implants and instruments with focus on Design for Reliability (DFR) and Design for Manufacturability and Assembly (DFMA) aspects.

o Assign part numbers, prepare detailed drawings and release models/drawings and documentation in Product Data Management (PDM) system for configuration control.

o Research and evaluate competitive products for performance deficiencies.

o Understand the inadequacy of existing designs and conceptualize/recommend alterations to development and design to improve quality of products/instrumentation and/or procedures.

o Lead the Integrated Product Team (IPT) to hold internal and customer design/manufacturing gated process reviews and incorporate feedback in the designs.

o Work within the Product Development procedures to create design control documentation.

o Assist in development of test procedures/protocols and testing of new and existing products.

o Determine necessity of testing and initiate testing of assigned products.

o Compile, evaluate and comprehend test data/results and implement/recommend appropriate design and procedure changes/updates.

o Interface with 3rd party suppliers, contractors, and testing houses as required.

• Lead multifunctional new product project teams, as assigned by Engineering Management, through project technical feasibility analysis, initiation, planning, and execution, adhering closely to project timeline and budget.
• Adhere to Medicus design control procedures to maintain design history files.

Additional Responsibilities:

• Coordinate with manufacturing department to perform time studies and provide process improvement feedback.
• Determine budgets and timelines for assigned projects.
• Report progress and status of assigned projects on a timely basis.
• Provide technical support to regulatory department for assigned projects as needed.
• Support Marketing and Business Development (BD) team with technical information as needed.
• Support surgeons, distributors, and customers in technical aspects of products.
• Assist with other development projects as additional resource when needed, while balancing own workload.
• Assist Quality team in development and improvement of inspection plans and techniques.
• Assist the Quality and Supply Chain departments to evaluate new suppliers to include in Approved Vendor List (AVL).
• May be required to travel to attend trade shows/meetings. Prepare trip reports as needed.
• Keep record of innovative ideas and assist on patent application preparation.
• Other duties as directed by engineering management.

Education/ Experience:

• Bachelor’s degree in Biomedical or Mechanical Engineering required.
• Minimum 2-3 years of design and development experience in the medical device (implants) industry.

Qualifications/Skills:

• Experience with CAD programs. SolidWorks experience preferred.
• Strong project management and communication skills required.
• Working knowledge of joint anatomy from an orthopedic standpoint required.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Knowledge of Biocompatibility and materials used in the medical industry desired.
• Prior experience in taking medical devices from idea generation to commercialization required.
• Manufacturing process (machining, plating, and coatings) knowledge required.
• Knowledge of medical device industry regulatory requirements including FDA 510(K) and ISO13485 guidelines for the development of medical devices required.
• Ability to understanding/interpret customer specification requirements required.
• High proficiency in MS Office and Teams environment.
• Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers.
• Ability to work independently and in a team environment.
• Proficiency in developing solutions to a variety of problems of moderate scope and complexity.
• Self-driven and work under minimum supervision. Perform duties with overall adequacy and accuracy.

Medicus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Employment decisions are made based on qualifications, merit and business need.

Job Type: Full-time

Pay: $63,278.03 - $123,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 10 years
• 11+ years
• 2 years
• 3 years
• 4 years
• 5 years
• 6 years
• 7 years
• 8 years
• 9 years

Schedule:

• Monday to Friday

Ability to Relocate:

• San Fernando, CA: Relocate before starting work (Required)

Work Location: In person