Senior Manufacturing Engineer

Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical device and biopharmaceutical companies.

We are seeking a Senior Manufacturing Engineer to join the Delano team. Responsible for the design and development of optimal engineering solutions for cost-effective lean manufacturing processes. Perform validation activities as necessary in a clean-room manufacturing environment. Recommends improvements to production processes, methods and controls. Supports and may manage manufacturing launch for new or revised products.

Responsibilities :

• Analyzes product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
• Develops manufacturing methods for new and existing products, establishes labor standards and develop product cost information.
• Performs validation activities as necessary in a clean-room manufacturing environment.
• Engaged in research and development for equipment, processes, procedures and systems integration.
• Meticulously documents all manufacturing process information and sequences within the site’s document control system.
• Identifies opportunities for improvement to existing processes and methods using data or observation, develops the improvements and implements them as quickly as practical.
• Makes improvements to production rates and reduces scrap by identifying and implementing new and better equipment, processes or human factor methods.
• Assists production in troubleshooting production problems with individual components, individual processes and help improve the situation to assure customer delivery dates and superior quality.
• Reviews production schedules and engineering specifications to resolve production problems.
• Serves as a member of the CAPA team, striving to implement permanent corrective actions.
• Participates in determination of product DMR disposition plan and approval.
• Follows all H&M Quality System protocols including ISO 13485 and 21 CFR part 11 and part 820.

Qualifications :

Required Skills :

Competencies :

Salary range : $95-115k depending on experience. Depending on qualifications and experience.

As a valued Trelleborg team member, you will enjoy :