This position is with one of our direct clients. Please send resumes to rraj (at) divihn (dot) com or call (630) 847 0285 with any questions.
Title: Design Systems Validation Engineer
The Design Systems Validation Engineer focused on RandD Product Design, will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for microsurgery business. The successful candidate will possess solid technical abilities, project management abilities, and leadership skills, bringing excitement and energy for product development, a passion for their work, and the impact it has on meeting the needs of patients.
1. Independently plan, execute and direct cross-functional engineering projects, that may cross traditional product lines. Diverse new approaches to problems encountered through adaptations and modifications of standard engineering principles.
2. Manage projects on a cross-functional basis, including direct supervision of team members.
3. Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross-functional expenses.
4. Identifying and resolve complex problems, including the development of new design experiments, without supervision.
5. Perform System Designer, and managing technical execution of multiple new product development programs.
6. Lead and drive the RandD resources assigned to projects to meet or exceed project targets in schedule, budget, and quality
Molding, over-molding, and micro-molding knowledge and experience preferred
7. Lead Technical Reviews and be the lead RandD voice in Design Reviews
Partner closely with Project Managers, Product Design Owners, and Quality Assurance; the primary point of contact for the project technical deliverables and interface with cross-functional teams, including Subject Matter Experts, Functional Managers, Project Management, and Senior Management
8. Guiding cross-functional teams through device design control processes with responsibility for translating project objectives into execution and specification levels
9. Expected to provide input to risk process, perform Engineering Investigations, and be a voice of knowledge for process development, problem-solving, issue resolution and risk mitigation
10. Directs teams in the determination of acceptability of correction, as assigned - corrective and preventative actions by considering impacts on performance, safety, costs, fielded product, manufacturing, and other factors
11. Prepares project reports, analyses and delivers presentations to leadership as requested
12. Provide scheduled written and verbal status to manager and RandD teams as needed
13. Coaches team members to ensure process adherence, technical design, and delivery, utilizing best design and development practices and project management skills.
14. Facilitates communication within assigned resources for execution tasks, owns and follows up on all assigned deliverables
15. Demonstrated success leading root cause analyses and implementing corrective actions (CAPA)
16. Knowledge and experience in test method development and validation; Ability to exercise independent judgment and draw conclusions based on available information
- Good communication skills with matrix management experience required.
- Independent judgment in the evaluation, selection, and adaptation of various engineering techniques required.
- Demonstrated experience with medical product development
- Completely proficient in relevant product and process development processes
- Recognized as a technical expert by peers and management
- Ability to organize and present technical and project management overviews without
- Demonstrated success in delivering results on several technical challenges
- Demonstrated strong process optimization and analytical skills
- Proven ability to create results within budget, timeline, and deliverables
- Self-motivated with good interpersonal skills, must be able to simplify the complex and speak to different audiences
- Understanding of and adherence to FDA, ISO and IEC design control procedures,
- regulations and standards
Education / Experience
- Bachelor of Science in Engineering (discipline: Mechanical, Biomechanical, Biomedical Engineering preferred) and 8-10 years' experience.
- 5 - 8 years recent and relevant work experience in a medical or regulated industry (prefers 8 years of experience)
- Medical product design experience required
- Experienced with all typical software tools (MS Office Suite, Minitab, CAD SW prefer SolidWorks). Must have experience or advanced training and demonstrate proficiency with CAD, TQM, statistical methods, problem analysis, and resolution, materials science, and design of experiments. Also needs to understand System Engineering tools to manage requirements (e.g. DOORS, etc.)
- Extensive cross-functional team experience, including technical and non-technical work
- Thorough, up to date knowledge of multiple disciplines required.
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.