Defined Term positions are contract roles of up to 12 months with eligibility for company health benefits and 401(K). Position could convert to permanent role or get extended but is not guaranteed.
- Designs medical devices and components.
- Designs, runs, and gathers data for a series of experiments.
- Implements design control requirements.
- Analyzes and documents test results in a laboratory notebook.
- Participates in the design of new test methods and procedures.
- Responsible for processing ECO's and DCO's (change orders).
- Responsible for implementing design control requirements.
- Responsible for analyzing customer needs and market requirements.
- Supports laboratory and clinical research.
- Supports production and manufacturing.
- Acts as project leader and coordinates design control process.
- Prepares reports and presentations and documents progress with senior management.
- Evaluates patents for specific technology areas and files patents as required.
- Vendor contract and specification development.
- Interface with other departments such as Customer Service and Sales & Marketing, Manufacturing, Regulatory and Quality.
- Communicates with physicians and other clinicians on product design and development activities and gathers feedback on product prototypes and clinical procedures.
- Assists in special projects as needed, inlcuding pilot builts, product testing and investigations.
- Contributes to team effort by accomplishing related duties as requested.
Perform CAD drawing peer reviews, with detailed understanding of ASME Y14.5 drawing and dimensioning.
Process engineering change orders to update drawings, documents and specifications.
Required Knowledge, Skills and Abilities:
- Good analytical and problem solving skills.
- Excellent written and verbal communication skills with good presentation and technical writing skills.
- Ability to manage resources and personnel.
- Working knowledge of tooling and medical manufacturing processes.
- Ability to thrive in a fast-paced, multidisciplinary environment.
- Understanding of FDA Quality Systems Regulations.
- SolidWorks CAD (v19) proficiency with ability to perform CAD concept,design, anlaysis and drafting.
- Plastics experience with injection molding, extrusions, materials and processes.
Understand Good Documentation Practices (GDP).
Experience with Medical Devices Quality Management Systems (QMS), Standard Operating Procedures (SOPs).
Medical Risk Management understanding of DFMECA and PFMECA documents, including detection, occurrence, and risk level mitigations.
Minimum Requirements: minimum requirements for the position.
- Bachelors or Master's degree in Engineering.
- Minimum of five (5) years direct product development experience in medical device industry or requivalent.
- Prefer prior experience with Class 3 medical products, such as cardiothoracic chest drains, catheters, etc
- Experience with medical devices from concept to commercialization.
- Strong computer skills including MS Office applications (Word/Excel) are required.
- Strong engineering, design, and analysis skills.
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