Compliance Engineer II bei Midmark Corporation
Midmark Corporation · Versailles, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Versailles
JOB SUMMARY:
The Compliance Engineer II assists in ensuring products comply with all the relevant safety standards by developing device requirements in alignment with those safety standards and evaluating the product to verify that those requirements are met.
ESSENTIAL/PRIMARY DUTIES:
- Manages compliance deliverables on new product development (NPD) projects and creation of required compliance requirements and test records.
- Assists in developing product requirements to ensure compliance with safety standards
- Conducts required product model compliance testing activities in compliance with ISO 17025 as specified by applicable compliance standards and Midmark procedures and work instructions.
- Analyzes test data and generates reports that detail the results of product testing, including product performance, material performance, failure modes, correlation studies, and other relevant analysis.
- Assists with safety risk management processes and creation of risk management documentation specific for compliance to safety standards.
- Communicates to both technical and non-technical stakeholders. Makes informed decisions within assigned tasks/projects and takes ownership of the outcomes.
- Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements.
- Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
- Expands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence.
SECONDARY DUTIES:
- Supports audits, as required, throughout the life of a device to ensure hazard mitigation and safety compliance is maintained.
- Designs and implements automation test equipment and software.
EDUCATION and/or EXPERIENCE:
Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both.
COMPETENCY and/or SKILL:
- Fundamental knowledge of safety standards (IEC 60101-1, IEC 61010, etc.)
- Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
- Strong written and verbal communication skills
- Advanced analytical skills, the ability to define and analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
SUPERVISORY RESPONSIBILITIES:
- Provides leadership, coaching, and/or mentoring to co-op’s and level I engineers.
Company
Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.
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