Product Development Engineer Medical Devices

SAGE PRODUCT DEVELOPMENT INC; South Foxboro (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Sage Product Development, LLC is seeking a seasoned Mechanical/Biomedical/EME engineer to lead medical device development programs on a contract basis. You will design, develop, and verify devices from concept to market, coordinating with clients and cross-functional teams.

You must have a bachelor's in relevant engineering, solid SolidWorks CAD skills, and proven project management experience in medical devices, with knowledge of FDA QSR and ISO 13485.

Qualifications

• Bachelor's degree in Mechanical, Biomedical or Electromechanical Engineering is required.
• Project management experience is required.
• Some prior medical device product design and development experience is required.
• Demonstrated ability to bring products from concept to market.
• SolidWorks 3D CAD proficiency is required.
• Knowledge of probability and statistics.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.

Responsibilities

• Manage product development projects and prepare project plans with phases, tasks, dependencies, durations, and resources.
• Design and develop medical devices from concept through market introduction; ensure regulatory and manufacturing requirements are met.
• Interact professionally with client companies and communicate status and updates.
• Generate innovative concepts and lead concept generation sessions; refine and rank concepts.
• Produce prototype devices and manage testing, evaluation, and documentation.

Skills

Project management

SolidWorks CAD

Probability & statistics

Entrepreneurial spirit

Education

Bachelor's degree in Mechanical, Biomedical or Electromechanical Engineering

Master's degree in engineering, management or business (plus)

Tools

SolidWorks

Job description

Direct Applicants Only.

COMPANY OVERVIEW:

Sage Product Development, LLC. provides fast, efficient and creative product development 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.

ESSENTIAL JOB FUNCTIONS (all as required by client companies):

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.

Some 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, Biomedical or Electromechanical Engineering is required. Master’s degree in engineering, management or business is a plus.

Project management experience is required.

Some prior 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 required.

Knowledge of probability and statistics.

Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

Familiarity with FDA QSR and ISO 13,485 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.

BONUS:

Experience in development of catheter-based devices.

Experience in electrical and/or electromechanical medical device design and development.

SUPERVISORY RESPONSIBILITY:

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

REPORTS TO:

Engineering Manager

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.