Manufacturing Engineer

Nuclein, LLC.; Austin (TX); On-site; USD 85,000 - 125,000; Full time

Job summary

Nuclein, LLC. in Austin, TX is seeking a Manufacturing Engineer to provide hands-on technical support for instrument and cartridge production and for production processes.

You will work closely with QA, production, supply chain, engineering and assay development to ensure on-time delivery of high-quality devices that meet regulatory and company growth demands. Essential duties include leading validations, developing fixtures and tools, and driving process improvements while ensuring FDA and cGMP

Qualifications

• Bachelor's degree in a relevant field required.
• 3+ years of experience in manufacturing engineering support in the medical device industry preferred.
• Experience with FDA regulations and cGMP (e.g., CFR 820, ISO 13485) desired.

Responsibilities

• Lead manufacturing engineering activities including validations and test equipment design.
• Develop and implement process improvements and lean manufacturing practices.
• Support CAPAs, MRBs, and 3rd party compliance audits.
• Create manufacturing instructions and training for direct labor.

Skills

Problem solving

Decision making

Collaboration

Attention to detail

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

Job description

The Manufacturing Engineer provides technical support to Nuclein cGMP manufacturing operations. This role will focus on instrument and cartridge production and production support. Position interfaces directly with Quality Assurance, Production Personnel, Supply Chain, Engineering and Assay Development to ensure the on-time delivery of high-quality devices in line with company growth and supply demands.

Essential Duties and Responsibilities:

• Lead and manage manufacturing engineering activities such as validations, test equipment design, test procedure development, process development and automation equipment implementation.
• Work with Development groups for the implementation of engineering changes to the manufacturing process
• Monitor production metrics and implement proactive corrective actions and process efficiency improvements as needed.
• Develop equipment, fixtures and tools that are needed for the manufacturing process.
• Ensure strict adherence to FDA regulations and GMP guidelines through process development and oversight.
• Resolve CAPAs and product Non-Conformances for the factory floor including supporting MRB functions
• Support 3 rd party compliance audits.
• Provide technical support for Design for Manufacturability and product changes
• Foster a culture of teamwork, accountability, and continuous improvement.
• Develop Manufacturing Instructions as required. Including training to Direct Labor as needed
• Develop and train processes to improve compliance and accountability such as Line Clearance and Label Line Clearance
• Implement lean manufacturing principles to streamline operations.
• Support development and direct support of instrument assembly manufacturing lines identifying needed equipment and test fixtures. Including process development, maintenance, training, and monitoring
• Work directly with suppliers to resolve Materials issues.
• Develop BOMs, routings and other manufacturing process documentation as required
• Support returned product rework and repair including work instruction and test procedure development

Education, Qualifications, and/or Experience:

• Bachelor’s degree in a relevant field
• 3+ years of experience in manufacturing engineering support responsibilities in the medical device industry. Specifically in instrument manufacturing is desired
• Experience operating in environments of FDA regulations and cGMP guidelines such as CFR820 and ISO13485-2016 is desired.
• Excellent problem-solving and decision-making skills.
• D emonstrated ability to drive process improvements and cost reductions.
• Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment
• Ability to operate independently with moderate supervision
• Possess a high level of attention to detail and organization
• Ability to prioritize tasks and to delegate them when appropriate
• Proficient with Microsoft Office Suite or related software to complete reports and logs
• Must be able to traverse the facility
• Must be able to lift 25 pounds at a time

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: > 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

THIS POSITION IS 100% ONSITE IN AUSTIN, TX. CANDIDATES MUST CURRENTLY LIVE WITHIN COMMUTING DISTANCE TO BE CONSIDERED. NO SPONSORSHIP IS BEING OFFERED AT THIS TIME.