Medical Device Engineer Contribute to the design, development, and manufacturing of medical devices. Works closely with senior engineers and cross-functional teams to ensure products meet regulatory standards and quality expectations.
Key Responsibilities:
Design and Development: Assist in the design and development of medical devices and components, ensuring compliance with industry standards and regulations.
Create Process Documentation: Prepare documentations including Part Processes, Routings, and Inspection documents.
Testing and Validation: Perform detailed analysis and testing to validate product performance and reliability. Document test results and make recommendations for improvements.
Documentation: Prepare and maintain technical documentation, including design specifications, test protocols, and reports.
Collaboration: Work collaboratively with cross-functional teams, including R&D, quality assurance, and production, to ensure seamless product development and manufacturing processes.
Process Improvement: Identify areas for process improvements and support initiatives to enhance product quality and manufacturing efficiency.
Troubleshooting: Assist in troubleshooting and resolving engineering issues that arise during development and production.
Compliance: Ensure that all engineering activities comply with relevant regulatory requirements, quality standards, and company policies.
Qualifications
Education:
Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field preferred or equivalent experience.
Experience:
0-5 years of relevant engineering experience, preferably in the medical device manufacturing industry.
Technical Skills:
Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools. Basic understanding of ISO 13485 and FDA regulations is a plus.
Analytical Skills: Strong analytical and problem-solving skills with the ability to perform detailed analysis and interpret data.
Communication: Excellent written and verbal communication skills. Ability to clearly document and present technical information.
Teamwork: Ability to work effectively in a team-oriented environment and collaborate with cross-functional teams.
Attention to Detail: Strong attention to detail with a commitment to producing high-quality work.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. 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. Equal Opportunity Employer This 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.
