Product Development Engineer

PRINCIPAL RESPONSIBILITIES:

• Plan and manage medical device product development efforts including customer interaction, specification and design input documentation, product design requirements, manufacturing process development, risk analysis, design control and process and design documentation.
• Create appropriate documentation required to validate the manufacturing process of a new product under TFX Design Controls Operational Procedures and ISO 13485 Quality System Requirements. Documents required but not limited to: Process Validation Protocols/Reports, Risk Assessment Protocols/Reports including PFMEA’s. This will also require the ability to create IQ, OQ and PQ’s as the fundamental core of each process validation. Process validations will include but not limited to: Thermal Bonding and Catheter Reflow, Injection Molding, Catheter Joining, Thermoforming and Packaging Pouch Sealing
• Participate in overall product development program management system including regular meetings and discussions around project priorities and project status updates.
• Prototype medical devices.
• Train and supervise technicians and assemblers in the manufacture of medical devices.
• Identify new manufacturing or product technologies for review and possible development activities within the product development group.
• Identify and manage vendor relationships to support introduction of new product designs to the market.
• Travel to customers, vendors and alternate manufacturing locations as needed.
• Apply appropriate quality procedures and product documentation to production builds and monitors each for quality conformance.
• Develop a complete understanding of TFX documentation system as it applies to manufacturing.
• Understand and utilize yield analysis data as a continuous improvement tool.
• Perform other duties as assigned.

EDUCATION / EXPERIENCE REQUIREMENTS:

• Bachelors degree in Engineering required. Mechanical, Chemical, Biomedical or related technical field is preferred.
• Individual must have a 2 to 5 years experience in medical device manufacturing.
• Prior experience with Medical Device Regulatory pathways is highly preferred.
• 2 to 3 years experience in catheter manufacturing or development is desirable.

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

• This position requires demonstrated communication skills, leadership and flexibility, and the ability to generate work instructions in oral, written and visual form.
• Proven track record for project management, problem solving, sound decision making and project competitions; the ability to manage development programs across multiple locations and project teams.
• Working knowledge of manufacturing processes related to catheter production, molding and extrusion.
• Working knowledge of QSR requirements for medical devices including design control for contract manufactured product and new product development efforts.
• This position requires exerting 10 pounds of force frequently and 50 pounds of force occasionally.
• The noise level in the work environment is usually moderate.
• To perform this position function successfully, an individual must be able to perform each essential duty satisfactorily.
• Advanced computer skills are required. Experience with Solidworks and Microsoft Word/Excel is required. Experience with Microsoft Project and MiniTab is preferred. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Prior training in Right to Know, GMP and Clean Room Procedures is required.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled