About Us:
Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 40 different Department of Defense awards from all military branches charged with medical technology development (i.e. U.S. Army, Air Force, Navy, and Space Force), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, Congressionally Directed Medical Research Programs, and Other Transactional Authority. As a prime contractor, Critical Innovations has a 99.5% rate of on-time program deliverable achievement. For Phase II awards, the company has 100% transition rate to Phase III funding. As a fully turnkey company, Critical Innovations possesses all the necessary capabilities and experience to guide a product seamlessly from proof-of-concept through to manufacturing, regulatory clearance, and commercialization.
Winner of the MTEC 2020 Prototype of the Year Award, Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR (cGMP) and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on agile engineering to rapidly advance products.
Position Title: Mechanical Engineer
Overview
The Mechanical Engineer provides technical guidance and aids multi-functional teams in design and development of device systems and or sub-systems. The Mechanical Engineer engages in all aspects of the device development process and lifecycle. This includes managing, planning, budgeting for the designs cost benefit analysis, optimization; prototyping, testing design iterations, developing effective testing methods, and leading early development through, design refinement, process development, and post-market activities.
This position involves tasks such as test reporting and data analysis; utilizing CAD and statistic analysis software to create, modify, and analyze designs. This position details hands-on prototyping and process development installation and operational qualifications of equipment, verification and validation activities. Performing laboratory-based bench top testing, maintenance of Design History Files and Quality System documentation, and participation in Risk Assessment and Risk Management processes.
This job is well suited to people who can ideate, conceptualize, and create innovative designs. This individual is able to work independently and provide effective project or program management. This person should have a broad range of expertise in research and development, design, test, and manufacturing, in mechanical and electro-mechanical fields. This individual should also have excellent communication, technical writing, problem-solving, and time-management skills. This is an on-site, full-time position.
The Mechanical Engineer will provide additional support to device development activities as assigned at the discretion of management.
Reports to:
VP of Production & Engineering
Duties and Responsibilities:
The Mechanical Engineer’s responsibilities typically involve:
· Lead or assist management in the planning of team activities with time critical resolution for milestone achievement, assist with the development of comprehensive project plans and project management tools.
· Lead or assist in lab and bench-top test, prototype budgeting. Develop and review prototype designs by both CAD modelling and hands-on prototyping, perform prototype evaluations, and support completion of device design to facilitate transfer to manufacturing (Good Manufacturing Practices).
· Ideate concepts to develop new components, subassemblies and technologies for suitability and functionality for all device and product development projects.
· Lead project teams to facilitate deliverables, production, review of documents and project status. Lead in the development and research of innovative production techniques and good manufacturing practices for all stages of device development.
· Lead in the team coordination to analyze and perform assessment of design prototypes for verification and validation activities. Lead in the coordination of device and product testing plans, draft technical protocols (Good Document Practices) and reports, including data analysis.
· Support maintenance of project documentation, including Standard Operating Procedures, Design Control Documentation, Design History Files, Quality System Documentation, and Risk Management Documents.
· Comply with FDAs Quality System Regulations and Phase based (Feasibility, Clinical, Commercial) Design Control practices while developing prototypes, test methods and processes, Non-Conformance, Root Cause Analysis, Change Control Management. Perform all documented work in compliance with ISO 13485:2016 and FDAs Quality System Regulations.
· Manage the coordination of suppliers to ensure completion of tasks within scope of the supplier classification, maintenance of supplier documentation, and incoming inspections.
· Lead in the IQ/OQ/PQ activities on new or developed lab equipment. Perform laboratory-based activities in support of prototyping and device development, testing, and evaluation.
· Lead in efforts to apply best practices in device design and application with human factors considerations, this can include instructions for use, ergonomics, and bio-compatibility assessments.
Skills and Experience:
The Mechanical Engineer should be able to utilize and develop existing skills and experience to find innovative ways to design devices; select design or apply test equipment and methods, to resolve any issues that arise, during the performance of any duties or responsibilities within both individual and collaborative group projects. The following abilities may aid the Mechanical Engineer in completion of these tasks:
· Excellent Communication both written and orally.
· Creativityto aid in finding innovative and different ways to create and design products, process, and manufacturing (Good Manufacturing Practices) techniques.
· Strong math skills, including calculus and statistics, to make accurate measurements and designs.
· Skilled with CAD (Solidworks) for creating, modifying, and analysis of, designs and components.
· Proficient in mechanical simulation and tolerance analysis techniques (e.g., Solidworks Simulation, Cetol).
· Ability to apply first order Mechanicals to resolve designs and models.
· Ability to read and produce prints, electro-mechanical, and mechanical schematics.
· Experience with metrology equipment (e.g. calipers, micrometer) for inspections and design purposes.
· Experience with human factors engineering and application of ergonomic data into product research and development.
· Proficient with Microsoft Office Suite, ability to perform statistical analysis.
· Ability to perform tasks within a lab environment, using standard and advanced laboratory equipment.
· Ability to lead and work well in a cross-functional collaborative team.
· Self-motivated with strong time management skills to ensure completion of tasks within strict timelines. Highly organized and detailed oriented.
· Must be able to lift 50 lbs.
Education and Training:
· BS or MS in Mechanical Engineering, or a related science field.
· 5-7 years’ experience in medical device or related field.
· Project or program management experience preferred.
Quality engineering experience a plus.
· Authorization to work in the United States indefinitely without restriction or sponsorship.
*Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.
* To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.
Work Remotely
Job Type: Full-time
Pay: $80,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Application Question(s):
- Will you be able to reliably commute or relocate to Los Angeles for this job?
Education:
Experience:
- medical device industry: 5 years (Required)
Work Location: In person