We are looking for an experienced, senior Mechanical Engineer to join our Philadelphia suburban location.
This individual will work with the client and a cross-functional team to develop new medical and consumer wellness products. The engineer will take an active role in design and development tasks including, but not limited to, project leadership, new concept generation, CAD modeling, prototype development, quality management, and testing. The ideal candidate should have 7+ years of proven experience and track record of creating new products in a medical device development organization.
Archimedic is a contract medical device development firm with offices in Philadelphia and Boston areas. We work with technology-driven companies to engineer and build electro-mechanical products for surgical, diagnostic, and drug delivery applications. We offer a creative work environment with a highly collaborative team, passionate clients, and technically challenging projects. Following are the responsibilities and requirements for the position:
- Mechanical Design: Define mechanical architectures and design mechanical systems, including mechanism layouts, PCB and electrical integration, thermal management features, structural chassis and housings.
- CAD Development: Utilize CAD to design components and assemblies. Apply master modeling, skeleton modeling and other advanced modeling techniques to provide top-down design continuity while ensuring multi-operator collaboration.
- Mock-ups & Prototype Development: Develop mock-ups to demonstrate and evaluate high risk areas of new product concepts. Develop prototypes to evaluate system-level models of full product designs. Select materials and fabrication processes as appropriate for design requirements. Facilitate debug and optimization through shop work and hands-on testing.
- Industrial Design Integration: Work with industrial designers to develop manufacturable solutions while maintaining usability and aesthetic requirements. Design housings and other external components using surface modeling techniques.
- DFMA: Identify the appropriate manufacturing materials and processes for all components, and modify designs to accommodate the relevant manufacturing requirements. Facilitate component design and assembly process reviews with manufacturing partners throughout the design process to ensure a smooth transition into production.
- Quality Management: Ensure that quality procedures are being followed, and documentation (design control, risk management) is in-place for all projects. Propose suggestions for process and documentation improvements.
- Project Management: Manage timelines, budgets and development processes to ensure that projects are completed to client’s satisfaction. Communicate progress, issues, and actions to client to ensure alignment.
- Supplier Management: Qualify, engage and manage key suppliers for specialty technical work, component fabrication, assembly, and other services needed for medical device development.
- Sales Support and Project Scoping: Work with sales personnel to engage new prospects and define project scopes. Assist with proposal development process and address technical issues during project discussions.
- Engineering Mentorship: Work with junior team members to coach on best practices for design, CAD modeling, prototyping and other engineering activities.
- Travel as needed: Travel as needed for client meetings, supplier meetings, and cross-office work. These could potentially involve over-night and weekend travel. In accordance with Company policy, Archimedic will pay for business-related travel.
- Other Responsibilities: Other responsibilities and activities may be assigned as needed by management.
- Bachelor's degree in Mechanical or Biomedical Engineering is required. Other advanced degrees are be advantageous
- Expertise with CAD modeling and analysis software, Solidworks experience preferred
- Experience with FDA QSR and ISO 13485 medical device regulations
- Experience with Risk Analysis tools consistent with ISO 14971
- Familiarity with EN 60601, Safety requirements for medical electrical systems
- Familiarity with US FDA regulations, i.e. 501(k), IDE, PMA
- Must be able to move throughout office and laboratory space, using a complete variety of office, inspection, laboratory equipment, and tools
- Must be able to stand for extended periods of time and use stairs to move between floors
- Must be able to lift up to 30 pounds
Archimedic recognizes that our team members are the foundation of our success. We provide excellent benefits and a great work environment.
- Competitive Salary
- Eligibility for discretionary bonus following 12-months of full-time employment
- Health Insurance with a choice of PPO or HMO. Archimedic pays a percentage of the premium.
- Dental Insurance. Archimedic pays a percentage of the premium.
- 401k plan with company match
- Company paid Short- and Long-term Disability Insurance
- Company paid Life Insurance Policy (2x Salary)
- Flex Spending Account
- Employee Assistance Program
- Worldwide Emergency Travel Assistance
- General vacation package, 8 holidays per year, 2 floating holidays per year.
- Eligibility for Educational Stipend after 12 months of full-time employment and dedicated time for continued refinement of professional skills
- There is no waiting period for benefits. They are active your first day of employment.
*The above statements are intended to describe the general nature and level of work being performed by team members assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
*Archimedic is an equal opportunity employer who considers its team members the cornerstone of the Company’s success. Archimedic does not discriminate against employees or job applicants based on their age, race, gender, religion, nationality or other protected characteristics.
*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.
Job Type: Full-time