Principal Mechanical Engineer

Job Title: Principal Engineer

Location: Irving, TX

Industry: Medical Device Manufacturing

Principal Engineer needed to join an Medical Device manufacturing company based in Dallas. This is an exciting full-time on site role, joining a company focused on orthopaedic devices.

In this key role, you will:

• Apply your expertise in technical engineering, people and process management, and environmental considerations to support R&D objectives.
• Manage new product development and concept and feasibility engineering efforts, ensuring organizational goals are met.
• Ensure products conform to established requirements and standards through appropriate audit, inspection, and test activities.
• Interact with internal stakeholders, suppliers, and external stakeholders to implement quality goals.
• Provide guidance and analytical skills to facilitate the design and development of new and existing products, ensuring quality standards are achieved.
• Oversee all aspects related to the quality of products, including manufacturability, supplier manufacturing, investigation of customer complaints, post-market activities, and corrective and preventative actions.
• Develop, modify, apply, and maintain quality standards and protocols.

Basic Qualifications:

• Bachelor's Degree in Engineering or a related field.
• Master's Degree in Engineering preferred.
• Minimum 10 years of experience in engineering, development, or research disciplines.
• Experience in the medical device or HCT/P industry, particularly Orthopedic, preferred.
• Background in additive manufacturing processes preferred.
• Experience with new product development and at least four product launches preferred.

Principal Duties:

• Provide technical and process guidance to both internal and external resources, and manage projects according to established budgets.
• Lead cross-functional teams to support R&D objectives, including mentoring, performance management, and project management.
• Manage customer relationships and develop user needs and marketing requirements from interactions with key stakeholders.
• Incorporate FDA, ASTM, and ISO standards into inspection and process control methodologies.
• Conduct risk assessments using current product quality data and other sources to identify issues, assess clinical risk, and offer design recommendations.
• Estimate and gather necessary information on timelines and costs related to new product development and concept/feasibility tasks.
• Review design documentation and create inspection and disposition plans for new products.
• Travel at least once a month to support company objectives.

Key Competencies:

• Proficiency in Solidworks and Microsoft Office Suite.
• Strong communication skills, both oral and written.
• Ability to lead clinical conversations with external stakeholders to determine critical user needs and marketing requirements.
• Experience or exposure to FDA regulations, ASTM standards, and industry tradeshows.
• Dynamic leadership skills and good interpersonal skills.
• Ability to work effectively in a small team environment and independently.
• Ability to work in a fast-paced environment and maintain a positive, enthusiastic, and problem-solving attitude.
• Advanced knowledge of blueprint creation, geometric dimensioning and tolerancing, additive manufacturing techniques, QSR/ISO regulations, design assurance, FMEA, and product testing methods.
• Ability to frequently lift up to 25lb and occasionally up to 30lb.