Product Conformity Specialist (m/f/d)

About the job

Making complexity accessible

Mikron Automation is your worldwide partner for advanced automation solutions. At Mikron we are committed to delivering the best assembly systems and all needed services throughout your product’s entire life cycle. With our extensive engineering know-how, complex process expertise, scalable platforms, and lifelong support we are driving lasting success for your business.

Your main activities

You ensure 100% product conformity with European regulatory requirements and Mikron safety standards, while developing a sustainable culture of compliance through initial training for the relevant professions and proactively managing non-conformities through corrective and preventive actions after analysis.

• Standard products, projects and equipment are 100% compliant with EU directives and Mikron safety rules.
• Be the guarantor of the "Machine Safety" methodology on site:
• Provide and update templates (HRA, Safety tests, Residual risks).
• Train new arrivals and maintain the skills of operational teams.
• Ensure legal and regulatory monitoring of directives and standards related to Mikron machine safety (non-exhaustive list):
• Machinery Directive 2006/42/EC --> Machinery Regulation (2023/1230).
• Electromagnetic Compatibility Directive 2014/30/EU.
• Low Voltage Directive 2014/95/EU.
• Cyber Resilience Act.
• ATEX Directive 2014/34/EU.
• Operationally support projects:
• Support the definition of machine safety concepts for the project-specific part during design.
• Intervene from the offer phase to conceptualise the complete safety system, integrating pharma URS if necessary.
• Identify generic solutions based on the state of the art.
• Provide standardised solutions for safety functions and safety tests of any Mikron machine.
• Define and maintain a compliance framework.
• Define and maintain an acceptable Mikron safety level.
• Provide expertise for Safety risk analyses (HRA).
• Expertise the safety impact analysis when modifying equipment installed on the client site.
• Lead the "CE - Safety" technical group:
• Communicate and implement the technical group’s decisions to operational teams.
• Organise meetings.
• Monitor training and recertifications of CE team members.
• Communicate and gather information on regulatory and normative updates.
• Adapt documents according to regulatory and normative evolutions.
• Provide expertise for coordinating "Machine Safety" activities between internal and external teams if needed (e.g. ATEX, UL).
• Report to the CE TEAM and have them decide on points raised by internal and external stakeholders (e.g. APAVE).
• Document and archive decisions and responses given to clients.
• Train employees according to their role and company needs.

Your profile

• HES level education or equivalent training in engineering with a focus on requirements engineering, systems and machine safety.
• Mastery of regulatory requirements regarding technical product safety (e.g. machinery regulation).
• Knowledge in automation.
• Knowledge in industrial cybersecurity (a plus).
• Knowledge of the legal framework "machine safety" with experience in risk analysis and safety-related investigations.
• Very good knowledge of French, good knowledge of English (and German a serious asset).
• Problem-solving and analytical mindset.
• Goal-oriented vision and priority management.
• Willingness to take on challenges.
• Appetite for innovation and automation technologies.
• Agility, flexibility and adaptability.

We offer you

• The opportunity to take on varied challenges and participate in the continuous improvement of an international company focused on the market and customer satisfaction in a constantly evolving technical environment.
• Project management centred on people and multidisciplinary teams promoting knowledge exchange and both personal and professional development.
• An international, modern, agile, multicultural and dynamic environment focused on teamwork.
• A position with opportunities for progression within a company attentive to the continuous training needs of its employees.
• A work-life balance.