Principal Engineer
At Acuity Surgical Devices, this key role will:
- Apply understanding of technical engineering, people and process management, and the environment to support R&D objectives
- Manage the plans and operations of the new product development and concept and feasibility engineering efforts ensuring organizational objectives and goals are met
- Be responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities.
- Interact with internal stakeholders, suppliers, and external stakeholders to implement Acuity Surgical Quality goals.
- Provides guidance and analytical skills to facilitate design and development of new and existing products to ensure that quality standards are achieved.
- Be responsible for all aspects (product and process) related to the quality of Acuity 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 an alternative Bachelor's degree program.
- Master's Degree in Engineering preferred.
- Minimum 10 years experience in engineering, development, or research disciplines
- Medical device or HCT/P industry, particularly Orthopedic, experience preferred
- Additive manufacturing process background preferred
- New Product Development experience with at least four product launches preferred
Principal Duties
- Provide technical and process guidance to both internal and external resources, assess and execute projects according to established budgets
- Provide project management oversight to all assigned projects
- 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 governing New Product Development (NPD) and sustaining quality standards/principles (ASTM, ASQ, etc.) into inspection and process control methodologies.
- Conduct Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance.
- Estimate and gather necessary information on timelines and cost related to new product development and concept/feasibility tasks for Project Planning.
- Reviews design documentation and creates inspection and disposition plans for new products via the use of an inspection requirements form attached to product drawings. Key reviewer of project documentation relating to design, compliance, and product testing. Final approver on product launch documentation.
- Travel at least once a month to support company objectives.
Key Competencies
- Solidworks
- Microsoft Office Suite
- Strong communication skills, both oral and written.
- Ability to lead a clinical conversations with external stakeholders (i.e., surgeon key opinion leaders) to determine critical user needs and marketing requirements.
- Experience or exposure to FDA regulations, ASTM standards, and Industry Tradeshows.
- Dynamic leadership skills; good interpersonal skills; ability to work effectively in a small team environment and build strong working relationships, as well as ability to work independently.
- Ability to work in a fast-paced environment; ability to work well under pressure and maintain a positive, enthusiastic, and problem-solving attitude.
- Advanced knowledge of blueprint creation and geometric dimensioning and tolerancing, additive manufacturing techniques, advanced understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and familiarity with various inspection tools and methods for medical devices.
- Able to frequently lift up to 25lb and occasionally up to 30lb.
Our customers depend on our integrity. Acuity Surgical Devices, LLC will provide quality medical devices and accessories that meet or exceed applicable national and international standards. Outstanding customer care, reliability, and improving each patient's quality of life are paramount.
www.acuitysurgical.com
Submit resumes to: ...@acuitysurgical.com