OEM Engineer - Entry Level (Onsite)

Come be a part of a dynamic team that is helping to make the improbable possible through innovation, customer relationships and support of our novel catheter-based, pressure sensing and telemetry technology, which is utilized worldwide in medical research, diagnostics and clinical treatment.

Millar works directly with customers and business partners to help push medical discovery to the next level. From mouse to man, our company plays an important role in medical discovery at every level. Join Millar during an exciting period of growth, as we take the opportunity to expand our clinical and research markets and leave a lasting impact on the medical community.

Job Summary

The OEM Engineer reports to the OEM Engineering Manager and supports the OEM Business Development, Research and Development, Manufacturing, Sales, and Marketing departments. This position utilizes engineering and project management skills to lead a variety of customer-facing projects from early feasibility to clinical production.

The OEM Engineer applies the practical application of the principles of engineering for the development and utilization of products, instrumentation, and processes. This position also creates and maintains device, component, and process related documentation for the OEM product line, as well as has a direct influence on design of customized prototypes and products.

Position Responsibilities

• Assists with managing OEM projects from early feasibility to clinical production.
• Responsible for creating and maintaining project timelines, budgets, and deliverables.
• Develops and documents OEM products and manufacturing processes for new OEM products.
• Develops and designs electrical / mechanical manufacturing or test fixtures and equipment.
• Drafts process validation protocols, and is responsible for process validations.
• Updates and maintains product or process related documents such as work instruction, manufacturing device specifications and component specifications using the engineering change notices process.
• Performs root cause analysis and resolves for OEM product manufacturing and quality related issues.
• Responsible for improving cost, quality, and delivery consistent with corporate objectives, current Good Manufacturing Practices (cGMP), and in adherence with all FDA and ISO requirements.
• Prepares cost estimates, reports, proposals, and presentations.
• Addresses and resolves production and customer problems related to product design.
• Shared responsibility for quality improvement and cost reduction of assigned products.
• Attends and supports at trade shows/conventions.
• Additional tasks and duties as assigned.

Education, Experience, and Knowledge

• Bachelor’s Degree in Mechanical, Electrical, Biomedical Engineering or equivalent.
• 1 – 3 years of experience in medical device manufacturing or design (catheter manufacturing a plus).
• Knowledge of developing a process from concept to full production release.
• Project Management skills.
• Advanced working knowledge of Microsoft Office, SolidWorks, project management software.
• Knowledge of 21 CFR, ISO-13485 is a plus.
• Experience conducting Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) is a plus.
• Capable of successfully managing concurrent projects independently and in a team environment.
• Excellent oral and written communication skills, attention to detail, and focus on quality a must.
• Ability to travel up to 10% domestically and internationally required.