Regulatory Compliance Engineer
- 825 University Ave, Norwood, MA 02062, USA
- FLSA Status: Exempt
Instron is a global organization that designs, manufactures, sells and services materials testing systems. Instron is a clear global leader in materials testing applications and its leadership in the marketplace is continually expanding. You will find that our established strength, commitment to our core values and team focus provides an engaging work environment and offers exceptional opportunities for personal and career development.
Reporting to Instron’s Quality Group, this position will be responsible for developing, maintaining, and executing the compliance program for the Instron static material testing division to achieve product compliance globally. This includes continuous review of relevant directives, laws, and standards to ensure the compliance program is current, product risks properly assessed and mitigated through design guidance, testing, auditing of completed compliance documentation and maintenance of all stored compliance technical files.
Essential Position Duties:
- Maintains current understanding of all regulatory requirements (directives, laws, etc,) and current industry standards for our products (design, testing etc.) and updates internal work procedures and standards to reflect these requirements. Communicates standards updates to the organization and provides periodic training.
- Assist in achieving product compliance
- For new and custom product designs by collaborating with the design engineering at all stages of development to provide guidance on the resolution of product and design issues to be compliant with international directives, laws, and standards in which the products will be sold. Review and approval of all compliance technical documentation for new and custom products. Document and communicate the project updates to internal customers and executives (if needed).
- For existing products by collaborating with manufacturing and service to ensure continued compliance of previously designed products during production, installation, and servicing. This will include creating and submitting reports or information as necessary (e.g. SCIP, EPA, UL, CARB, etc.).
- For all products by collaborating with the testing teams, external labs, reviewing design data and creating final analysis and reports of validation of product compliance (e.g. EMC).
- Responsible for sign-off of EU CE certificates for all products.
- Serve as the company’s chief safety officer
- Responsible for leading a team of safety officers from a variety of engineering disciplines and groups
- Coordinating communication with customer, service, manufacturing, and legal around incidents, questions and investigations in the area of product safety from the field.
- Provide regular training to engineering on design practices for safety and compliance
- General skills
- Ability to work in a constant state of alertness and safe manner
- Ability to understand and perform additional new compliance related duties as assigned
- Proven strong attention to detail, interpersonal, communication and organizational skills, and the ability to create, collaborate and work within team environments.
- Working with other organizations such as Marketing, Manufacturing, Engineering and Service to address their questions or issues as they arise.
- Effectively communicate both up and down the organization.
- Requires at least a Bachelor's degree in Engineering Safety, Mechanical or Electrical engineering discipline
- At least 2 years relevant experience in regulatory compliance (preferably machinery related)
- Good verbal and written communication skills
- Attention to detail
- Preferable experience: Product development, product testing and project planning
- Directive/law experience:
- Prop 65
- EU Machinery Directive
- EU Low Voltage Directive
- EU EMC Directive
- EU Waste Management Directive (RoHS/WEEI/REACH).
- Standards experience:
- ISO 12100 Risk assessment and reduction
- ISO 13849-1, ISO 13849-2 Control safety system design
- IEC 60204-1 Electrical safety
- ISO 13850, ISO 13857, ISO 14119, ISO 14120 Guarding, and Interlocks
- UL Standards
Take this opportunity to join a professional and successful team where you can make a significant impact immediately. Enjoy competitive compensation and generous benefits that includes health, dental, life and LTD insurance, paid parental leave, 401k (with match), and a generous tuition reimbursement program.
Instron is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.