Manufacturing Process Engineer

Occlutech; Bakırköy; On-site; TRY 240,000 - 420,000; Full time

Job summary

Occlutech is seeking a Manufacturing Process Engineer to optimize and validate production processes for cardiac devices. The role focuses on interface across Production, R&D and Maintenance to ensure robust, efficient manufacturing throughout the product lifecycle.

The candidate will manage equipment acquisition, supplier coordination, machine start-up, validation support and documentation, while driving quality improvements and CAPA activities on the shop floor.

Qualifications

• Experience in the medical device industry is preferred.
• Knowledge and experience in development and implementation of manufacturing systems and processes.
• Experience in project management.
• Experience in risk management (especially Process FMEA).
• Knowledge of Medical Device Manufacturing standards, audits and inspection techniques.
• Knowledge of CAD tools preferred.
• Experience with QMS according to ISO 13485.

Responsibilities

• Interface between Production, R&D, and Maintenance to ensure robust production processes throughout the product lifecycle.
• Specify equipment and coordinate with suppliers; support validation and documentation.
• Lead manufacturing-related activities for changes and continuous improvements; transfer designs to production.
• Support CAPAs, ECRs and other QMS-related processes in Manufacturing.

Skills

Process engineering

Manufacturing systems

Project management

Risk management (P-FMEA)

QMS ISO 13485

Communication

English (B2)

Tools

CAD tools

Job description

Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 190,000 products sold. The company markets and sells its products in over 80 countries and has around 330 employees.

Registered in Switzerland, Occlutech employs around 300 people and has manufacturing and R&D facilities in Germany and Türkiye, a global finance and distribution hub located in Helsingborg, Sweden, as well as clinical operations in Minneapolis, U.S.

Manufacturing Process Engineer (m/w/d)

We are offering position in the medical device sector with ambitious and passionate people building meaningful products for patients all over the world.

Our work environment is dynamic and allowing for collaboration with smart people and knowledge sharing in cross functional teams. allows for more flexibility for our employees.

Working Days: Monday–Friday (07:30-16:30)

Reports to : Global Director Manufacturing

Direct Reports: None

Your work will focus on

• The process engineer acts as the interface between Production, R&D, and Maintenance to ensure manufacturable, robust, and efficient production processes throughout the product lifecycle. Leads manufacturing-related activities for product changes, continuous process improvements, and the transfer of new product designs into production.
• Acquisition of production machines: specification of machines, communication with suppliers and support in the purchasing process, initial start of the machines, support in validation process up to approval, documentation. Similarly with fixtures and tools.
• Quality improvement: root cause analysis for quality issues in production and implementation of improvements; close collaboration with Quality Control
• Improvement of production processes: identify potential improvements and develop improvements.
• Documentation: documentation of all root cause analysis / improvement analysis actions up to final implementation; creation and / or revision of documents such as work instructions, forms etc. needed for all processes in production; proper documentation of all activities.
• Application of a risk- and economy-oriented approach to work.
• Follow safety rules with the manufacturing area and throughout the company site.
• Follow SOPs and establish work processes.
• Work in a timely manner on CAPA’s, ECRs and other QMS-relevant processes related to the Manufacturing department.
• Collaborates with other departments, Occlutech sites and stakeholders to maintain an effective manufacturing process.
• Regularly analyzes all manufacturing process; suggests improvements to increase efficiency and profitability for the company.
• Supports maintenance activities by providing technical expertise for production equipment, troubleshooting, process improvements, and equipment modifications.
• Pro-actively and regularly report to the direct supervisor on activities and timely informs about deviations from timeless including the proposal / implementation of corrective actions.

We are looking for a candidate, who

• Experience in the medical device industry preferred.
• Knowledge and experience in development and implementation of manufacturing systems and processes.
• Experience in project management.
• Experience in risk management (specially Process FMEA)
• Knowledge and experience of Medical Device Manufacturing standards, audits, and inspection techniques.
• Knowledge of CAD tools preferred.
• Experience in quality management systems, preferably on QMS according to ISO 13485
• Ability to handle job stress and interact effectively with others in the workplace.
• Excellent verbal and written communication skills
• Excellent interpersonal skills with a proven ability to create and maintain positive working relationships with all internal & external stakeholders.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• English knowledge at least at the CEF level B2.

If you are a motivated and experienced Manufacturing Process Engineer looking to make a difference, we would love to hear from you.