MECHANICAL DESIGNER/ENGINEER, Medical Devices Job in Golden 80403, Colorado Us

Unisyn Medical Technologies (www.unisynmedical.com) is a private equity-backed national provider of total lifecycle medical imaging solutions to the diagnostic imaging industry. Unisyn leverages its proprietary technologies and advanced technical capabilities to provide high quality, cost-efficient solutions for its customers across multiple modalities and vendor platforms. We are expanding rapidly in terms of geography, market share and service offerings and are looking for high-energy, self-directed, highly motivated professionals interested in contributing to the growth and success of the Company.

We are currently seeking a MECHANICAL DESIGNER/ENGINEER to join our Ultrasound Probe Repair team.

Status: Regular, Full-Time, Exempt
Location: 1150 Catamount Drive, Golden, CO

Roles Responsibilities:
The Mechanical Designer/Engineer collaborates with engineers and technicians to perform repair part reverse engineering tasks, development tasks, and repair operations support tasks, including hardware and parts design, test and validation, and documentation.
• Reverse engineer repair replacement parts using Solidworks.
• Perform design verification and validation experiments and testing.
• Help implement process improvement using Lean Manufacturing/Demand Flow concepts.
• Document work performed as needed to meet compliance and regulatory requirements.
• Support manufacturing and repair, including assistance in resolution of design and manufacturing problems and review of proposed changes to design or manufacturing methods.
• Specify parts or service suppliers and manage supplier/parts issues.
• Generate and help implement applicable work instructions and procedures relevant to repair operations.
• Creating molds for parts casting and hands on mechanical work will be required.
• Assist in the coordination and implementation of corrective actions associated with repair services or products.
• Assist in the investigation of complaints.

Requirements:
Education Certifications
• Associates Degree preferred
Experience
• 5 years of experience as a mechanical designer in a regulated industry preferred
• 5 years of experience with CAD software is required; experience with Solidworks preferred
• DOE and SPC software experience a plus
• Experience with or training in Lean Manufacturing and 5S principles desired
Travel
• Reliable transportation
Competencies
• Excellent oral and written communications skills.
• Ability to work in a regulated medical quality environment
• High level of attention to detail and accuracy
• Strong organizational skills and ability to prioritize tasks
• Excellent verbal and written English language skills
• Ability to establish and maintain effective working relationships with co-workers, customers, and vendors
• Ability to react quickly and adapt to changes in priorities, circumstances and direction
• Ability to work effectively with minimum supervision