Job Category: Quality Engineer
Job Id: 2114
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.
What we are looking for
The ideal candidate for this position has experience as a member of product development teams in the medical devices, aerospace, or other regulated industries. This candidate’s experience will include reviewing and providing feedback on requirements, supporting risk management, developing test plans and procedures, participating in configuration management and configuration audits for certificate of conformity generation, and preparing certification-ready reports and document collections. This candidate is detail-oriented, has a strong knowledge of development and/or production processes, and likes to see projects through to their finish.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Participate as project team member in support of Systems Engineers and other engineering disciplines
- Apply expertise in processes, standards, and tools to provide requirements interpretation and compliance design support to the product design teams and suppliers
- Interpret relevant standards and apply risk management practices on projects in medical, aviation, and space industries
- Participate in requirements elicitation with an emphasis on testability and relevance
- Consult with design engineers to provide guidance on aspects of regulatory and statutory requirements that affect the design and design decisions
- Support product configuration management and documentation compliance
- Review and edit content created by others to ensure that project documentation is ready for release and submission
- Develop and lead the development of test plans and procedures and conduct validation and verification (V&V) testing of requirements, and support the acquisition of test equipment and data to support V&V activities
- In coordination with Project Managers and Systems Engineers, lead transition of designs from development into manufacturing
- Plan and lead statistical process control efforts in production environments
- Support teams in investigating root causes of failures in process or product and following nonconformities to complete resolution
- Support teams in the presentation of objective evidence of conformity during audits
- Minimum of a bachelor’s degree (B.S.) from a technical college or university, in an engineering, natural sciences, or computer science field.
- Years of industry experience depend on the job level assigned.
The skills listed below are representative of the knowledge, skills, and/or abilities desired.
- Regulatory Affairs experience and/or training
- Experienced CAPA champion
- Knowledgeable of statistical processes is strongly preferred
- Demonstrated experience in a procedure-controlled configuration management environment
- Demonstrated experience working with and ability to interpret quality standards such as IEC 60601, IEC 61010, 21 CFR 820, ISO13485, DO-254, DO-178, DO-160, ARP 4754, ISO 13485, ISO 14971, and AS9100
- CQE, CQA, Six Sigma Green Belt, or Six Sigma Black Belt certificates beneficial
- Demonstrated ability to establish proficiency in new regulatory areas
- Software Quality Assurance and development capabilities
This position specifically requires the ability to create, read, analyze, and interpret complex documents in English and to respond effectively to inquiries and complaints. Individuals who fill this role must demonstrate consistent aptitude in creating accurate, succinct documentation appropriate for review and release; and for critically reviewing content created by others. Individuals must be able to present information effectively and respond professionally to questions from peers, supervisors, and customers.
To perform this job successfully, an individual should be proficient with business applications including, but not limited to: OpenAir, MS Word, Excel, PowerPoint, Outlook, SharePoint, and MS Project.
Familiarity with Minitab and/or Model-Based Systems Engineering (MBSE) software a plus (Cradle, CORE, Doors).
Note: Due to the nature of work, only US Persons (citizens or permanent residents) need apply for this position
Salary range: $65K - $110K