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 NOTESARCH 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.
