Our direct client is looking for a Product Engineer – Medical Device for a 6-month Contract to Hire OR Full Time Direct Hire in Dallas TX area
- 6-month Contract to Hire (temp to perm) / Or open for Direct Hire Full Time
- Work Location: Farmers Branch, TX 75244
- Onsite role Monday – Friday
- In-Person Interviews are required
- Close to Galleria Dallas Mall and Carrollton TX area; North of Dallas Love Field Airport
Our clients Medical Innovation team is working diligently to provide best in class technology solutions for medical environments. We are looking for a design engineer with system level medical device product realization and lifecycle management experience. The successful candidate will be responsible for product design and development activities including product development, documentation, change control, verification and validation and safety testing, product transfer to production of medical devices used in the Operating room environment.
- Responsible for providing design leadership and solutions for robust product designs and activities needed to meet key business objectives.
- Supports material/design/process changes to the product line through Design Control process, with well-documented research/analyses.
- Designing and developing products from conceptual stage through production model status, which are safe, reliable, effective and economically feasible
- Researching the feasibility of designing safe, reliable and effective products based on product specifications
- Component research, assessment and selection to ensure best performance and cost price
- Writing product Requirement Specifications and other related product design documentation
- Managing product development timelines and budgets.
- Leading multidisciplinary design team meetings to review processes, feasibility, the suitability of materials or to determine best-manufacturing practices is essential.
- Lead the development of Risk Management File FMEA and risk analysis documentation for each product.
- Coordinating and Lead Design Review project meetings
- Development of V&V Plans and Protocols
- Developing applicable functional block diagrams, schematics, bill of materials, prototype and production model test requirement specifications, etc.
- Supervising the construction of prototypes to ensure they are safe reliable, and effective
- Managing prototype product testing and Regulatory and Safety testing process
- Preparing the documentation required to manufacture and test all products
- Assist in developing product training materials and participating in training
- Adhering to all Company and QMS policies and procedures
- Maintaining communications with all personnel required to effectively perform all duties
- Maintaining an engineering log of daily activities relative to all product design activities
- Identify best in class design practices and lead the implementation of these into the regular lifecycle management of products.
- General task management though Task Clarification, Concept Generation, Detailed Design, Product.
- Design includes the generation of full DMR documentation for transfer to production.
- Ability to coordinate and execute Regulator Safety Testing to IEC 60601.
- Physically lift, without aid of material handling equipment or the aid of co-workers, a maximum of 50 pounds
- Available for afterhours work.
- Available for travel on short notice
- All other duties as assigned by management
- Bachelor's Degree in Mechanical Engineering, Electrical Engineering or a related field is required.
- As this is a senior position a minimum five - ten years of professional design experience is required; and/or a minimum of ten - fifteen years equivalent of experience and education from which comparable knowledge, skills and abilities have been obtained.
- Formal Six Sigma Certification (green belt minimal) is desired.
- Familiarity with best practices in Product Lifecycle Management.
- Highly self-motivated and directed.
- Ability to analyze and develop solutions for departmental issues.
- Ability to multi-task in an energetic environment.
- Knowledge of current technologies, manufacturing principles, practices and procedures.
- Knowledge and skill in project management and principles.
- Ability to train and develop subordinates to independently coordinate their personal responsibilities, which may include detailing and general program organization.
- Skill in performing detailed and complex numerical computations and reports.
- Skill in both verbal and written communication.
- Working knowledge of FMEA and Hazard Analysis
- Working knowledge of IEC-60601 and ISO-14971
- Working knowledge of EMI
- Knowledge of AutoCAD software.
For immediate consideration please submit your resume in Word format, along with daytime contact information. LOCAL CANDIDATES ONLY PLEASE unless you are willing to relocate yourself at your own expense. Client is unable to provide H-1B Visa sponsorship at this time. All submittals will be treated confidentially. Selected candidate may be asked to pass a comprehensive background, credit and/or drug screening. Principals only, no third parties please.
Established in 2000, Atrilogy Solutions Group, Inc. provides organizations of all sizes with high-quality, cost effective information technology (IT) and business process consulting & staffing services. Our industry-leading service model combines experienced project managers with seasoned technical and functional consultants to eliminate client uncertainty and deliver superior value and results.
Clients turn to Atrilogy for expertise in:
- IT staffing and placement (Project Managers, Agile/Scrum Masters, Business Analysts, DBA’s, Software Engineers, Mobile Developers (iOS, Android), DevOps, Automation, QA, Systems & Network Engineers, Cyber Security / Information Security Specialists)
- All major ERP & CRM packages (including Oracle, Workday, PeopleSoft, JD Edwards, Lawson, SAP, Dynamics AX, Salesforce, Microsoft CRM, NetSuite)
- Business Intelligence, Data Warehousing, and Big Data Integration
- Creative (Interactive Project Manager/Art Director, Information Architect, UI/UX Designer, Web/Graphic Design)
Atrilogy has been recognized by Inc. magazine as one of the nation’s fastest-growing, privately-held companies. Headquartered in Irvine, California, Atrilogy also has offices in Denver, Phoenix, Atlanta, and Dallas with satellite offices in Boston, Jersey City, Las Vegas, Seattle, and Delhi, India.
Atrilogy Solutions Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.