Lake Forest, IL
Permanent Position
Description for Principal Engineer –
Device Design Control: Seeking a Principal Engineer to
be responsible for ensuring the Design Control process is compliant with
FDA and global regulations and that the requirements of these regulations are
appropriately translated into company procedures and applied to directly to
product development to avoid FDA and global findings.
Responsibilities for Principal
Engineer – Device Design Control:
Lead Development of Design Controls process &
accountable for successful project completion.
Plans and directs major technical phases of projects.
Provides technical direction and coordinates team efforts. May be responsible
for directing assigned engineering and support staff.
Represents business unit on projects. Routinely provides
analysis and advice to senior business unit management.
May be responsible for training/mentoring less-experienced
exempt and non-exempt personnel in area of expertise. Responsible for the
performance evaluations of all reports. Resolves complex problems within
teams, departments, projects, programs and cross-functionally. Manages
activities of reports to achieve goals consistent with area, department,
R&D and business unit objectives.
Applies advanced theories and concepts. Optimizes
solutions from a systems point of view by taking into account the effect of any
change on other parts of the systems and supporting functions.
Designs/modifies complex systems. Designs/modifies
complex/ high-level systems architecture requiring multidisciplinary expertise
or in-depth knowledge in a single discipline; defines parameters and boundaries
for lower level design activities. Establishes error budgets for key aspects of
system performance.
Integrates multiple project plans. Establishes and reviews
complex plans for multiple activities/projects or plans highly complex personal
projects; monitors and takes corrective action for processes and systems.
Identifies, creates and leads new methods for verification
and validation.
Suggests/applies novel ideas/solutions to customer needs
both inside and outside of organization. Suggests/applies recognized leading
technologies to project teams.
Exchanges information with appropriate frequency and
within a time frame to maximize its utility and promote cross-functional
collaboration. Delivers communications tailored to the needs of the
receiver (managers, peers, customers). Conveys information clearly and
effectively through both formal and informal documents; reviews and edits
written work constructively. Defines purpose and objectives; prepares and
delivers clear, smooth presentations; carries self well in front of a group;
keeps to time frame; can effectively field questions.
Requirements for Principal Engineer – Device Design
Control:
- 10+
years experience in Design and Development with demonstrated experience in
the development of electro-mechanical systems design, consumables products
or drug/device combination products.
- Expert
knowledge of FDA 21CFR820; in particular 820.30, Good Manufacturing
Practices (GMP), and ISO 13485 and ISO 14971.
- Demonstrated
expertise in requirements management, configurations management, defect
tracking, and associated tools.
- Advanced
experience with establishing departmental or program objectives following
company policies and establishing
procedures that are measureable with outcomes that can be quantified. - Advanced
experience with complex, cross-functional development projects
- Strong
ability to converse technically with mechanical, electronic, software,
clinical, regulatory, and quality engineering disciplines.
- CSQE,
CQE, CQA or other ASQ certification preferred.
Expert knowledge required in the following areas:
- Design
and Development Planning
- Design
Input & Output
- Design
Review
- Design
Verification & Validation
- Design
Transfer
- Design
Changes
- Design
History File
- Risk
Management
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