6 month contract position based on-site at a medical device supplier site in San Antonio, Texas and will report directly to the VP of Manufacturing who is based in the UK. The purpose of the role is to add expertise and be the company's on-site representative to ensure all supplier manufacturing activities and output conform to company, regulatory and quality specifications and are delivered on time and within budget.
Key responsibilities include:
• Develop the supplier to improve the production line so that it can be fully validated, output improved and scaled up.
• Working with software ISO 13485,
• Develop the supplier to execute the relevant Validation Plan, pFMEA, DOE, IQ, OQ and PQ documentation and protocols.
• Use structured problem solving techniques identify root causes of defects and implement corrective actions.
• Ensure supplier documentation meets the required standard, delivered on time and within required specification, raising CAPA's and NCR's when required.
• Provide regular progress reports to company management and key stakeholders, highlighting current issues, risks and possible strategies for managing and mitigating those risks.
• Identify, recommend and develop the supplier to implement approved changes which improve productivity and reduce cost and scrap.
• Promote strong cooperation between the Supplier and customer, fostering supplier accountability and a quality mindset.
• Organization: The Sr. Manufacturing Engineer will work closely with customer's onsite Sr. Quality Engineers well as remotely with the HQ Quality, Manufacturing and R&D teams.
Manufacturing engineering, Process improvement, Manufacturing process, Assembly, Continuous improvement, Work instruction, Process engineering, Process validation, Supplier development, Iso 13485, Class II medical device, Corrective action plans
- Class II Medical device manufacturing
- ISO 13485 (Quality management systems)
- Supplier development
- Production line process validation
- Assertive Personality/Self Starter/Hands On & Productive Mentality
• Bachelor's degree in Biomedical, manufacturing, mechanical engineering or equivalent
• 5-10 years applied manufacturing experience in the medical devices, in a Class II medical devices company (assembly, production, packaging)
• Proven track record managing and delivering projects against strict quality parameters, on time and within budget
• Manufacturing scale up and process validation experience
• Knowledge of Risk Management, ISO 13485 and applicable Quality System Standards
• Extensive supplier development experience
• Self starter, assertive characteristics, hands on, multi tasker
• Practical experience and advanced knowledge in machining processes, tooling technology, mechanical assembly, testing and
• Fluency in English
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.