Senior or Principal Product Development Engineer

COMPANY OVERVIEW:

Sage Product Development, Inc. provides fast, efficient and creative product development and low to mid volume production services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure. We solve client companies’ technical challenges and meet their product development needs in a timely, efficient and highly personalized manner.

We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their product development engineering abilities, and build their network within the industry.

GENERAL SUMMARY:

• Develop medical devices from concept through market introduction on a contract basis for client companies
• Meet or exceed customer expectations
• Position is based in our Santa Clara, CA location
• Experience and expertise with catheter development and/or surgical robotics development is desired

ESSENTIAL JOB FUNCTIONS:

• Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the project’s client company.
• Generate project timing and expense estimates and prepare project proposals for client companies.
• Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.
• Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
• Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.
• Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.
• Investigate and evaluate existing technology for application to projects.
• Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.
• Produce prototype devices for testing and evaluation. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.
• Conduct bench and/or animal feasibility studies.
• Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.
• Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.
• Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.
• Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations.
• Maintain detailed essential product and process documentation throughout all phases of research and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete and well organized.
• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Ensure that all work satisfies the requirements of client companies’ Quality Systems, with particular emphasis on Design Control.
• Conduct and document Design Reviews.
• Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.
• Date, sign and have witnessed all documents that may establish inventorship dates.
• Significant local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).

OTHER DUTIES AND RESPONSIBILITIES

• Any other duties as assigned.

REQUIRED COMPETENCIES

Customer Focus

• Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.

Management of Resources

• Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

 Communication Skills

• Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:

• Bachelor's degree in Mechanical or Biomedical Engineering is required. Master’s degree in engineering, management or business is a plus
• A minimum of five years of medical device product design and development experience is required
• Demonstrated ability to bring products from concept to market
• Ability to interact with client companies in a professional manner
• SolidWorks 3D CAD proficiency is desired but not required
• Knowledge of probability and statistics
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit
• Familiarity with FDA QSR and ISO 13485 medical device regulations
• Depth of knowledge in one or more clinical areas
• Depth of knowledge in one or more medical device product areas
• Depth of knowledge in one or more technical areas, for example finite element analysis
• Pre-clinical (animal) experience

Desired Catheter Experience:

• A solid foundation of clinical and anatomical knowledge relating to procedures that utilize cardiovascular catheters and neurovascular catheters
• Hands-on assembly skills related to the development of catheter prototypes and subsequent testing
• Catheter knowledge and skills: Experience and knowledge in the development of catheter-based devices, including such features and processes as: Thermoplastic elastomers and polymers, Hydrophilic coatings, Nitinol, stainless steel, and nickel based alloys, Components, Liners, Braided shafts, Marker bands, Coils and torque wires, Compliant and non-compliant balloons, Electrodes, Stents: self-expanding and balloon expandable, Polymer extrusion: single and multilumen, Coating and dipping, Adhesive bonding, Skiving and drilling, Laminating, reflow and joining processes, Tipping, Laser welding, Testing, Bencht top testing such as Trackability pushability, flexibility, torqueability and radial force, Balloon characterization
• Design of test fixtures to complete the above

Desired Robotics Experience:

• A solid foundation of clinical and engineering knowledge relating to surgical robotic systems, specifically the development of the surgical or endoscopic end-effectors.
• Hands-on skills related to the development and testing of surgical robotic end effectors.

SUPERVISORY RESPONSIBILITY:

• May direct the work of other people, and may have direct reports.

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment
• The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required
• External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis