What are the responsibilities and job description for the R&D Engineer position at Medical Engineering Consultants (MEC)?
Job 2804 - R&D Engineer - Contract located near Sand Diego, California
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Onsite
Job Purpose
Develops products, materials, processes, and equipment for projects of moderate complexity. Under limited supervision, plans and executes engineering activities to support product development, sustaining engineering, manufacturing, and process improvement initiatives. Compiles, analyses, and reports operational, test, and research data to establish performance standards for new or modified products, processes, and materials.
Key Responsibilities
Build quality into all aspects of work by ensuring compliance with applicable quality system requirements, design control procedures, documentation standards, and regulatory requirements.
Qualifications
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Onsite
Job Purpose
Develops products, materials, processes, and equipment for projects of moderate complexity. Under limited supervision, plans and executes engineering activities to support product development, sustaining engineering, manufacturing, and process improvement initiatives. Compiles, analyses, and reports operational, test, and research data to establish performance standards for new or modified products, processes, and materials.
Key Responsibilities
- Contribute as a core team member on product development, sustaining engineering, and process improvement projects.
- Support product design activities, including concept development, design modifications, prototyping, and engineering documentation.
- Plan and execute engineering studies, experiments, and testing activities to support design and process decisions.
- Create and maintain engineering documentation, including specifications, protocols, reports, drawings, and design records.
- Utilize CAD software (e.g., SolidWorks) to support product, fixture, tooling, and test equipment design activities as required.
- Design, procure, and coordinate fabrication of tooling, fixtures, and test equipment.
- Investigate technical issues related to product design, materials, manufacturing processes, and product performance.
- Analyze test results, identify trends, and formulate data-driven conclusions and recommendations.
- Support engineering change activities and implementation of design or process improvements.
- Collaborate with Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to achieve project objectives.
- Support development and maintenance of technical files, risk management documentation, and design history records.
- Generate innovative ideas and contribute to intellectual property and product improvement initiatives.
- Plan and manage individual work activities to meet project milestones and deliverables.
- Provide technical support and guidance to technicians and other team members as required.
- Demonstrate knowledge of Product Development Process (PDP) and Technology/Product Development (TPD) systems through delivery of high-quality engineering outputs.
Build quality into all aspects of work by ensuring compliance with applicable quality system requirements, design control procedures, documentation standards, and regulatory requirements.
Qualifications
- Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Product Design, Materials Engineering, or a related engineering discipline.
- 0-2 years' experience within the Medical Device Industry.
- Experience supporting product development, sustaining engineering, or manufacturing projects preferred.
- Strong analytical and problem-solving skills.
- Effective communication and technical writing skills.
- Ability to work independently and collaboratively within cross-functional teams.
- Working knowledge of CAD software (SolidWorks preferred) is desirable.
- Ability to interpret and create technical drawings and engineering documentation.
- Experience analyzing and presenting technical data.
- Understanding of engineering fundamentals, design principles, and manufacturing processes.
- Strong organizational skills with the ability to manage multiple priorities.
- Experience within a regulated industry, particularly medical devices, is advantageous.
- Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred.
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.