Medical Device Quality Assurance jobs

Position Title: Compliance & Certification Engineer III

Department: Research & Development

Reports To: Engineering Manager – Certification and Compliance

Summary:

Leads and directs others in certification and compliance aspects of new product development and value engineering projects. Responsible for defining the scope of work for certification and compliance of products to meet required domestic and international agency standards. Work with project engineer lead to prepare documentation to submit for agency approvals. Ensures agency listings are in compliance at all times. Actively participate and support Regulatory Affairs team with standards working groups and industry committees. Lead internal/external product performance audit programs to ensure compliance to minimum performance levels. Support technical services with field issues related to product code compliance.

Essential Functions (To perform within this position successfully, the incumbent must be able to perform each essential duty satisfactorily. Other duties may be assigned.)

• Responsible for assuring that all products are evaluated and are compliant to all applicable US and international codes and standards, that all safety and regulatory issues have been reviewed and approved, and that product remains in compliance.
• Act as technical expert for Product Development Team, collaborate with internal and external partners, factories, as well as third party labs, to evaluate products and critical components, facilitate testing protocols, and review third party reports.
• Work with regulatory agencies globally to ensure compliance for all water products and accessories.
• Ensure Process for Maintaining records of product compliance and make them available to other departments.
• Participate with product development team to identify, document, and remediate risks during development product life cycles. Participate in new product development risk assessments to examine and address physical, chemical, and electrical hazards. Participate in design reviews and failure mode analysis to assess hazards over life of product.
• Act a technical expert to provide regulatory guidance, and interpretation of standards for all areas of the company.
• Determine applicable requirements and verify compliance of water heating products to latest US and international electromechanical product safety standards including ANSI, UL, CSA, NOM, EN, IEC, LVD, EMC, ERP, NSF, and others.
• Determine applicable requirements and verify compliance of water heating products to latest US and international performance and products listing requirements including AHRI, DOE, Energy Star, NRCan, CEC, GSO, SASO, and others.
• Determine applicable requirements and verify compliance of water heating products to latest US and international chemical and material regulations including TSCA, CA Prop 65, RoHS, REACH, and others.
• Participate in design reviews to confirm critical components meet Rheem requirements and have valid certification listings. Review certification submittals and work with appropriate agency to complete all listing activities. Complete verification of listing and provide certificates for publication. and audit with engineering and factory
• Coordinate with the product team on the development of product labels, markings, consumer warnings and user instructions, in accordance with regulatory and Rheem requirements.
• Ensure accuracy of labeling, product markings, and consumer warnings and instructions.
• Lead and direct others for internal and external product performance audit programs to ensure compliance to minimum performance levels and design requirements. Work closely with product engineering leadership to address findings with performance to ensure compliance to minimum efficiency requirements.
• Engage directly and direct others to work with product engineering leadership, product management, and operations to initiate new projects due to regulatory changes that affects product design, performance, or strategic advantage in the market.
• Interface with third party agencies and factory personnel during audits, product inspections, and follow-up services. Lead and direct others on activities with support of product engineering leadership to close follow-up service items or variance notices issued.
• Actively participate and monitor industry and regulatory agencies for emerging or changing standards and regulatory requirements with potential for product impact or business risk. Lead discussions with third party agencies about interpretation of standards. Promptly report any findings to product teams and management.
• Represent Rheem as a member in industry councils, symposiums, and training to extend Rheem’s expertise, network of resources, and reputation as a company dedicated to product integrity.
• Responsible for effective communication, coordination, and working relationships with company personnel, external clients, customers, contractors, and officials
• Engage directly and direct others to work with Regulatory Affairs Department on product safety and regulatory compliance related activities.
• Ability to travel Domestic and International approximately, 20-30%
• Provides regular progress reports to management

Basic Qualification:

• Bachelor’s degree in Engineering (EE, ME, IE) or equivalent combination of education and experience in related discipline.
• Certification or specialized training in regulatory or product safety evaluation preferred.
• Minimum 5 years of certification and compliance related experience. Preference is given to practical experience in evaluating consumer products to conformity standards, ANSI, UL, NOM, EN, or IEC based.
• At least five years of experience in a manufacturing environment preferred. Knowledge of various domestic and foreign manufacturing disciplines.
• Technical expert of electro-mechanical design of consumer appliances is desirable.
• Technical expert in the application of standards, relevant testing protocols, and in applying professional judgement on compliance and the significance of non-compliance.
• Technical expert of domestic and international regulatory and compliance schemes: UL, CSA, FCC, CB Scheme, CE Directives (LVD, EMC, Energy Efficiency), and others
• Technical expert of chemical regulatory compliance requirements and management, including RoHS, REACH, CA Prop 65, TSCA, Biocides.
• Proven experience in managing the certification process of consumer products, including experience with third party agencies like CSA, UL, ETL, CE, CCC, BSMI, etc., is desirable.
• Proven Experience of IoT development licensing requirements and standards is desirable.
• Leadership experience in record stewardship for internal and external audit purposes.
• Master level of knowledge of Microsoft Word, PowerPoint, Excel, Project, Power BI and document control systems.
• Strong working knowledge of laws, standards, regulations, industry best practices, and current trends in the field for domestic and international consumer goods.
• Experience with DFMEA/PFMEA preferred.
• Experience with Stage Gate Product Development Process preferred.
• Demonstrated ability in analytical reasoning, problem solving and critical thinking skills.
• Excellent written and verbal communication and documentation skills. Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
• Ability to translate complex regulatory information into compelling stakeholder-friendly language, including the importance of regulatory compliance and impact to product design or production.
• Ability to critically review detailed technical information and assess whether arguments are presented clearly, and conclusions are adequately supported by data.
• Ability to identify risks, competently advise on applicable requirements, and recommend mitigation plans.
• Skilled in project and time management and maintaining schedules in a fast- paced environment.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.

Preferred Education & Experience:

• Master’s degree in Engineering (EE, ME, IE) with minimum 5 years of experience in the application of standards, relevant test protocols, and in applying profession judgement on compliance and the significance of non-compliance
• Minimum 5 years of experience in certification and compliance of appliances.
• Certification or specialized training in regulatory or product safety evaluation preferred.

Pay: $100,000.00-$123,000.00 per year

Benefits:

• Dental care
• Extended health care
• On-site parking
• Paid time off

Work Location: In person