Product Development Engineer

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, and vision benefits
• Company-paid life insurance and disability benefits
• Self-managed (unlimited!) PTO and 11 paid holidays
• 401k Plan with Company Match
• Tuition Reimbursement

COMPANY OVERVIEW

Meraqi Medical, now a part of Viant Medical, provides design, development, and manufacturing services to medical device companies in the bioelectronics, interventional and structural heart, and minimally invasive surgical spaces. Meraqi provides solutions from early brainstorming, conceptualizing and prototyping, to full design and development, as well as clinical and commercial manufacturing.

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

POSITION SUMMARY

Supports assigned customers to assure best in class design and quality for product and provides seamless communication between Meraqi and customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Design and develop class III implantable devices
• Ensure designs meet performance specifications, regulatory and manufacturing requirements
• Manage product development projects.
• Prepare, track, and communicate project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Coordinate tasks and schedule.
• Use software to develop detailed 3-D CAD models and drawings
• Interact with customers in a professional manner. Proactively communicate with customers to ensure an ongoing two-way exchange of information.
• Maintain Design History Files.
• Assemble and/or evaluate prototype devices.
• 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.
• Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
• Promptly respond to product issues, taking appropriate action within the Meraqi Quality System and continually building strong rapport with customers and suppliers.
• Collaborate with all departments to develop optimal work order routings and Device History Records.
• Lead the generation of redlined documentation and review prior to sign off.
• Lead and oversee the training of Assemblers/Technicians/Inspectors as needed.
• Oversee the generation of process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ) and lead the implementation of protocols and completion of reports.
• Lead customer specific team meetings.
• Perform other activities as directed.
• Complete accurate daily time card

REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE

• Bachelor’s degree in Engineering is desired
• 3 years of medical device product design and development experience or equivalent is preferred, catheter experience desired
• Demonstrated ability to bring products from concept to market
• Ability to interact with client companies in a professional manner
• Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards
• Depth of knowledge in one or more clinical areas
• Depth of knowledge in one or more product areas
• Depth of knowledge in one or more technical areas (ie sterilization)
• Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit

PAY RANGE

We offer market competitive compensation. Potential salary range for this role is $95,000-$160,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.