Hardware Test Engineer (Medical Devices)
We’re ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we’ve been helping our clients develop products that are changing the world, whether that’s by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world’s most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don’t have to take our word for it that we are a great place to work—we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.
About the Role:
- Hardware tests for laser ablation capital system
- Conducting formal verification tests and writing reports.
- Open to candidates with computer science, mechanical engineering, and electrical engineering background
- Need familiarity with PLM tools, MS office, Defector Issue Tracking tools.
- Familiarity with with EE and ME benchtop equipment is needed.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Responsible for plans, schedules and equipment required for testing including tool/fixture/phantom design.
- Compiles data and defines changes required in test equipment, testing procedures, manufacturing processes, or new testing requirements.
- Frequent use and application of technical standards, principles, theories, concepts, and techniques.
- Responsible for verification and validation of new or changed products including generating plans, protocols and reports for testing performed.
- Create, develop and maintain test software
- Ensures test equipment is in good working order and calibrated, as necessary
- Coordinates and oversees the testing of equipment and product at outside test facilities.
- Sets up and develops test tracking, monitoring and data recording systems.
- Provides solutions to a variety of technical problems of moderate scope and complexity.
- Participate in all phases of product development as needed such as reviewing requirements, design, usability, risk assessment and defects.
- Design, implement and/or execute automated testing.
- Identify and implement process improvements.
- Participate in defect tracking and analysis.
- Troubleshoot, debug, maintain, and support existing products.
- Effectively communicate findings, problems and solutions to project teams and stakeholders.
- Collaborate and maintain excellent working relationships with team members and stakeholders.
- All activities must be performed in compliance with the Quality System.
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
- All other duties as assigned
Education/Experience
- Minimum of a B.S. / B.A. degree in Engineering.
- 2 + years of relevant experience with a Bachelors' degree
- 0+ years of relevant experience with a Master's degree or higher
Qualifications;
- Knowledge of applicable AAMI, ISO, FDA, ASME, IEC, and EN standards
- Working knowledge of hardware design, development, root cause analysis and test practices.
- Oral and written communication skills.
- Ability to work in a team environment.
- Self-motivated with strong problem solving skills and the ability to work independently.
- Able to handle multiple tasks/projects and manage priorities.
- Excellent written and verbal communication skills, including the ability to communicate effectively with business and technical audiences
- Mechanical cycling of instruments
- Cleaning instruments in a semi-automated washer
- Sterilizing instruments using an autoclave
Desired Skill Sets:
- Experience with medical device testing and understanding of FDA Quality System Regulations (QSR)
- Able to handle multiple tasks/projects and manage priorities
- Experience with test automation including GUI, integration and stress testing and designing and implementing test automation frameworks.
- Ability to work in a fast paced, collaborative team environment. Experience with Agile and iterative development practices is a plus.
- Project management skills including planning, estimation, tracking and communication
- Self-motivated with strong problem-solving skills and the ability to work independently
- Machine shop experience.
- Knowledge of statistical methods.
Location: On-site in Lafayette, CO
Salary Range: $80K - $100K
The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience
ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.
Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.
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