US Compliance Engineer Job

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JOB OVERVIEW:
This position is responsible for managing compliance requirements in development and maintenance of medical devices and accessories and associated design file documentation. Developing and implementing processes to ensure medical device projects/products are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of the company's quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and support in verification, validation and problem solving.
KEY RESPONSIBILITIES:
Achieves product and engineering compliance by ensuring product regulatory compliance in product development and product surveillance and completing documentation including Product Risk Management, compliance plans and approving product development documentation.
Prevents compliance issues by collaborating with engineering planning and design teams, reviewing design data, and developing compliance plans and requirements.
Partners with Regulatory Affairs in defining and execution of Regulatory Plans in product development projects.
Identifies and resolves product and engineering design issues by identifying short-term and long-range issues.
Researches and identifies applicable regulatory and industry compliance standards and codes.
Develops compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria.
Adapts and modifies compliance engineering options.
Develops and evaluates new compliance methodologies.
Organizes compliance plans by preparing researching and communicating applicable regulatory and international standards requirements.
Determines compliance by establishing compliance test standards, partnering with engineering in conducting and witnessing tests, performing diagnostic procedures, measuring performance, analyzing and evaluating findings, and performing forensic analysis and troubleshooting of failures.
Attains compliance by isolating and resolving compliance issues, recommending product and process changes, and initiating engineering change orders.
Documents compliance by completing approval applications, recording test results, preparing investigative reports, preparing, and filing Declarations of Conformity, and maintaining compliance database.
Maintains engineering team accomplishments by reviewing open issues and action items, coordinating actions, and contributing information and analysis to team meetings and reports.
Prepares compliance reports by collecting, analyzing, and summarizing measurement data and trends.
Updates job knowledge by tracking and understanding emerging compliance engineering practices and standards, participating in educational opportunities and professional organizations, reading professional publications, and maintaining personal networks.
Enhances engineering and organization reputation by accepting ownership for accomplishing new requests and exploring opportunities to add value to job accomplishments.
Implements product testing and process analysis.
MINIMUM WORK EXPERIENCE:
A minimum of 3 years' experience working as a compliance engineer ideally within the medical device industry, including roles within product development or manufacturing engineering. Experience in a disciplined engineering environment.
PREFERRED EDUCATION:
BS in industrial, mechanical, electrical, or environmental engineering or related field, required; master's degree in engineering a plus.
2-3 years relevant work experience in a manufacturing environment, preferably in compliance
3 years' experience in medical device industry regulatory compliance including experience in 21CFR, EU MDD, EU MDR and applicable ISO and International Standards.
GENERAL SKILLS & COMPETENCIES:
Intimate knowledge of medical device regulatory requirements and standards including 21CFR, EU MDD, EU MDR and applicable ISO and International Standards.
Intimate knowledge Risk Management practices and processes including ISO 14971.
Knowledge of production planning, manufacturing methods and procedures and quality control
Critical thinking and problem-solving skills
Data analytics skills
Organization, project management, and strategic planning skills
General math skills
Familiarity with process improvement methodology
Excellent verbal communication and documentation skills
Attention to detail
Understanding of regulatory frameworks
Experience with computer-aided design software
SPECIFIC KNOWLEDGE & SKILLS:
Strong working knowledge of medical device regulations including 21CFR820, EU MDD, EU MDR
and other global regulatory requirements and quality system standards including ISO14971 and other relevant standards.
Demonstrated success in the implementation of problem solving methods and tools
Understanding of the effective implementation of the entire risk process, including the
identification and implementation of appropriate controls in product development and/or operations.
Experience in product verification/validation, process validation and test system development and implementation. Experience in the development and implementation of processes and testing meant to satisfy quality and regulatory standards in the medical device industry, as well as drive product and process quality.
Practical experience with the implementation of statistical tools and techniques.
Experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects.
Strong understanding of best practices related to supplier quality and supplier development
General knowledgeable in computer system validation and related regulatory requirements
TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS:
Travel - typically less than 10%
Position typically works in an office environment whether on site or remote where environmental conditions are stable
While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds
Position requires that the employee use eye protection at all times while working
Brasseler USA is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

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