About KNOW Bio
KNOW Bio, LLC is a life science company redefining the standards of care in a number of diseases and medical conditions. Utilizing our extensive catalog of intellectual property in the fields of Nitric Oxide and precision light therapy, we form subsidiaries that develop unique treatments to revolutionize the standard of care for many indications. KNOW Bio then supports each subsidiary by forming teams of experienced and talented personnel - at both the KNOW Bio and subsidiary levels - to accelerate the development and deployment of those treatments.
Opportunity
We are searching for a self-motivated Senior Sustaining Engineer to join our engineering team in Morrisville, NC. The incumbent engineer will play a pivotal role in planning, development, and implementation of engineering activities in support of design transfer, design changes and process improvements to new and existing product lines.
Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or assume responsibility for on-going sponsorship of an employment Visa at this time.
Job Title: Senior Sustaining Engineer
Reports To: Director of Engineering
Key Responsibilities:
- Independently interface with suppliers to coordinate design transfer of new products, design changes, and process changes
- Evaluate proposed product design and process changes using engineering principles, generating and approving necessary design and change control documentation to ensure compliance with regulatory and quality standards
- Lead the Change Control Board (CCB) by maintaining an updated status of all active design and process changes, scheduling and leading weekly CCB meetings to review change statuses, and summarizing action items to ensure timely execution
- Develop and implement product enhancements to improve reliability, reduce costs, and extend product lifecycle
- Execute and coordinate process validation activities including development of validation protocols, oversight of study execution, data analysis, and final report authoring to ensure manufacturing processes consistently produce products meeting predetermined specifications and quality attributes
- Generate and maintain project plans, timelines, and budgets while tracking progress against established milestones, identifying potential risks or barriers, and presenting solutions to keep projects on track
- Develop detailed specifications for components, assemblies, fixturing, and gauges
- Design and conduct experiments, analyze data using appropriate methods, and summarize results to generate proper conclusions and recommendations
- Investigate data anomalies and unexpected results to determine and understand the root cause
- Collaborate with cross-functional teams including engineering, quality, regulatory, manufacturing, and marketing to ensure project success.
- Execute duties and leverage resources, including vendors and consultants, in the most efficient manner possible (balancing cost and effectiveness) to ensure the company will maintain developmental timelines without sacrificing quality standards.
- Perform other duties and analyses as requested by members of management
- Adhere to and ensure compliance with Revian's quality system
Required Skills & Qualifications:
- BSc, MSc, or PhD in an engineering or physical science field
- 5+ yrs of experience in the medical device industry and within a Quality System compliant with 21 CFR 820 or ISO 13485
- Prioritize and manage multiple projects in a fast-paced environment with minimal supervision while maintaining strong attention to detail
- Self-starting and self-motivating team player with the ability to work autonomously
- Willingness to quickly adapt to changing priorities and manage multiple tasks, including performing tasks outside normal job hours, duties, and education
- Strong interpersonal skills, effective written and verbal communication, problem solving, and decision-making skills
Desired Skills and Qualifications:
- Prior experience of eQMS systems, such as Arena or Agile
- Knowledge of ASME Y14.5-2009 and Geometric Dimensioning & Tolerancing (GD&T)
- Proficiency of SolidWorks or comparable 3D CAD Software
- Experience with optical components, measurement methods, and measurement equipment
- Familiarity with manufacturing processes such as SMT, machining, molding, thermoforming, and assembly methods
- Proficiency with MiniTab, JMP, R or other statistical computing software
- Detailed knowledge of Microsoft Project, Smartsheet, or other project management software
- Knowledge of IEC standards (e.g., IEC 60601) relevant to electromechanical medical devices
Location & Travel Requirements.
- This is an onsite role located in Morrisville, NC. The successful candidate will be required to work at our Morrisville, NC facility during standard business hours. Remote or hybrid work arrangements are not available for this position
- Travel up to 40% to suppliers, contract manufacturers, or other locations may be necessary to support business objectives. Specific travel schedules will be communicated in advance.
- Candidates must be able to travel domestically and internationally as needed.