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.
