Staff R&D Process Development Engineer
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Job Location:
Campbell, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
01-11-2025
Vacancies:
1 Vacancy
Job Summary
Location: This position is based in our Campbell California offices. This position is hybrid and full time.
Why Imperative Care
Do you want to make a real impact on patients Imperative Care is changing the way stroke is part of our team youd be developing breakthroughs that will revolutionize the future of stroke care. Every day the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient and they come first in everything we do.
What Youll Do
As a member of our R&D organization you will take the lead on product and process development projects for neuro-interventional medical devices with a focus on building stable robust and capable manufacturing processes. The scope includes defining characterizing optimizing and validating processes as well as driving equipment development and improvements internally and at supplier/contract manufacturer sites.
The position requires someone who thrives on solving complex problems applying structured engineering approaches and translating design requirements into practical manufacturable solutions. Work will span from early concept development through scale-up with heavy emphasis on process characterization (DOEs data analysis) equipment and fixturing design and rigorous documentation.
- Process Development:Own the development of new processes and improvement of existing onesdriving definition characterization optimization and validation.
- Technology Innovation:Identify evaluate and implement new process technologies that advance our manufacturing capabilities.
- Equipment Development:Lead the design qualification and improvement of manufacturing equipment and fixturing.
- Process Characterization:Plan design and mentor execution of DOEs to establish process windows control limits and workmanship standards.
- Data-Driven Problem Solving:Apply DMAIC and other analytical methods to identify root cause reduce variation and drive robust solutions.
- Cross-Functional Collaboration:Partner closely with R&D QA/RA and Operations to define manufacturable product specifications visual standards and workflows that ensure smooth transfer into production.
- Documentation & Control:Lead documentation of equipment and processes ensuring compliance with best practices quality system requirements and regulatory standards.
- Supplier Engagement:Participate in the management development and qualification of external supplier processes.
- Culture & Quality:Actively support our Quality Management System and promote a culture of rigor safety and continuous improvement.
What Youll Bring
- BS in Engineering with 8 years of related experience or MS with 6 years (medical device or other regulated industry preferred).
- Strong background in process characterization validation and scale-up in a controlled environment.
- Skilled in analytical/statistical methods (DOE SPC) with proficiency in Excel and Minitab.
- Solid knowledge of FDA Design Control DFSS/DFM tools GMP/GDP and relevant standards (ISO 13485 FDA QSR).
- Excellent critical thinking able to connect cause and effect prioritize under constraints and deliver practical solutions.
- Experience in pilot and production line setup validation and scale-up.
- Proven ability to work independently and to lead/mentor others.
- Strong communication and project management skills.
- Molding experience is desirable.
- Ability to travel as required.
Join Us! Apply Today.
Salary Range: $/annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position candidates work experience education/training key skills and internal equity as well as location market and business considerations when extending an offer.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
Required Experience:
Staff IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Accelerating the development of life-changing technologies to bring more care to more patients suffering from stroke and other devastating vascular diseases.
