Plays a critical role in leading the design, development, and optimization of medical devices. This position requires extensive technical expertise, project management skills, and the ability to mentor junior engineers. The Senior Engineer ensures that all products meet regulatory standards and quality expectations, driving innovation and continuous improvement within the organization. This role requires 7-10 years of extensive quoting experience and design for manufacturing experience specific to complex medical instrumentation, devices, and implants.
Key Responsibilities:
- Project Leadership: Lead and manage complex engineering projects from concept through production, ensuring timely delivery and compliance with industry standards and regulations.
- Design and Development: Develop innovative medical devices and components, utilizing advanced engineering principles and practices. Oversee the entire product lifecycle, from initial design through to manufacturing and post-market support.
- Regulatory Compliance: Ensure all engineering activities adhere to relevant regulatory requirements, including ISO 13485 and FDA regulations. Prepare and review technical documentation to support regulatory submissions.
- Quality Assurance: Implement and maintain robust quality control systems. Conduct detailed analysis and testing to validate product performance and reliability. Address and resolve any quality issues that arise during development and production.
- Mentorship: Provide technical guidance and mentorship to junior engineers. Foster a collaborative and supportive team environment that encourages professional growth and development.
- Process Improvement: Identify opportunities for process improvements and lead initiatives to enhance product quality, manufacturing efficiency, and overall operational effectiveness.
- Cross-Functional Collaboration: Work closely with R&D, quality assurance, production, and other departments to ensure seamless integration of new products into manufacturing processes. Facilitate effective communication and collaboration across teams.
- Technical Expertise: Stay current with industry trends, emerging technologies, and regulatory changes. Apply this knowledge to drive innovation and maintain the company’s competitive edge.
Qualifications:
- Education: Bachelor/Masters degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, preferred or equivalent experience.
- Experience: Minimum of 5-10 years of engineering experience in the medical device manufacturing industry, with a proven track record of leading successful projects.
- Technical Skills: Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools. Deep understanding of ISO 13485, FDA regulations, and other relevant standards.
- Project Management: Strong project management skills, with the ability to manage multiple projects simultaneously. Experience with project management software is a plus.
- Analytical Skills: Excellent analytical and problem-solving abilities. Capable of performing complex analysis and interpreting data to make informed decisions.
- Communication: Superior written and verbal communication skills. Ability to clearly document and present technical information to diverse audiences.
- Leadership: Demonstrated leadership and mentorship capabilities. Ability to inspire and guide a team of engineers toward achieving common goals.
- Attention to Detail: High level of attention to detail with a commitment to delivering high-quality work.
ADDITIONAL NOTES
ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
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Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Top Skills
What We Do
American Manufacturing, Serving the World
We are driven by precision. Our engineering expertise and precision-machining capabilities serve the medical, aerospace and defense, and industrial markets. We offer a synergy of resources to reduce your manufacturing costs, optimize the performance of your components and products, and cut your supply chain risks.
ARCH has multiple state-of-the-art facilities that manufacture high-quality cutting tools, precision-machined components, and products. Working with ARCH, your business gains the advantage of an expanding range of cutting-edge resources for all your precision-machining needs. Our facilities are strategically located across the U.S. to optimize your outsourced precision-machining needs.
We strive to be your trusted and proactive partner. ARCH is structured to provide the capacity, flexibility, and scalability you need to succeed. We offer design-for-manufacturability, prototyping, on-site application testing, program management, technical support, and customized services.
The rise of American manufacturing requires the support of highly evolved and collaborative precision-machining partners. Our comprehensive experience in critical part production across a broad range of applications allows us to provide a dynamic range of solutions.
We truly understand the critical nature of the components and products we work with and are intently focused on delivering exacting quality to our customers, and ultimately to their customers. We combine leading-edge expertise and industry standards to ensure consistent quality at every step.
To maintain our leading edge, we invest in the continuous improvement of our manufacturing and quality assurance processes. The sharing of knowledge, technologies, and best practices across our teams strengthens our competitive advantage, accounting for performance breakthroughs, value creation, and cost containment.
