Medical Device Engineer
- Subject Matter Expert on medical device production and testing
- Subject Matter Expert providing inputs to technical documentation related to medical devices and production processes (Specifications, Risks Assessments, etc.)
- Subject Matter Expert providing inputs to medical device design changes from manufacturing and testing point of view
- Technical point of contract between production site and the design and development area
- Troubleshooting for medical devices production at ALK and suppliers
- Participate and eventually lead on Risk Analysis sessions, preparing risk analysis documentation
- Working closely with Production department / CMO’s to troubleshoot processing problems and develop solutions that supports business objectives and overall production strategy
- Propose and implement improvement projects that improve compliance, efficiencies, yields or throughputs
- Provide engineering support in developing new or improving existing equipment and/or processes related activities
- Participate on design, commissioning and qualification of medical devices production and testing equipment
- Root cause analysis and solution implementation to equipment and process related non-conformances utilizing the approved company processes
- Play a key role in any inspection, technically defending medical device manufacturing and testing processes and controls
- Provide detailed response to observations related to the above activities
- Preparation of Work Instructions and SOPs
- Onsite lead activities requested by the design and development area to be performed at the manufacturing and testing site
- Degree on Science or Engineering
- Demonstrated capability of working under Medical Device Regulation. FDA environment is desirable.
- Advanced level of English spoken, written and understood.
- Experience of at least three years in similar position.
- Technically sound in operation and trouble shootings of machines and manufacturing processes
- Knowledgeable in Quality Systems and Design Control standards, policies, procedures and methodologies
- Desirable: knowledge on plastic and silicon molding, metal stamping and device assembly
Skills & Abilities
- Willingness to change
- Conflict resolution
- Analytical skills
- Decision making
- High level of independency / initiative.
- Objective driven profile.
- Collaboration / Teamwork
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. The job is very flexible and you have very much influence on your daily work.
17th February 2018
For further information on the position please contact Leticia García, HR Development Consultant - email email@example.com
17th January 2018, LGJES
ALK is a global research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. We are the world’s leading company within allergy immunotherapy. We are constantly moving forward as we have maintained our pioneering spirit. We are large enough to offer you both challenges and good opportunities for development, but not large enough for you to disappear in the crowd.
We have experienced success and significant growth in recent years, and together with our international partners we work to expand the use of allergy immunotherapy worldwide. Therefore we need employees who both desire and are capable of influencing the company.