Job summary
Job post source
This job is directly from cGxPServe
Job overview
The Principal Engineer at cGxPServe leads technical efforts in sustaining engineering for disposable medical devices, focusing on design history file (DHF) structure and ensuring regulatory compliance.
Responsibilities and impact
The role involves managing third-party supplier documentation, overseeing change controls, leading DHF creation and maintenance, coordinating R&D efforts with global stakeholders, and managing engineering projects with adherence to FDA and international regulations.
Experience and skills
Candidates need a BS in Mechanical, Plastics, Biomedical Engineering or related field (MS preferred), 5-8 years in Class II or III disposable medical product development, expertise in FDA Design Controls, ISO 13485, risk management standards, and experience in supplier and change control management.
Company overview
cGxPServe operates in the engineering and information technology sectors, specializing in research services with a focus on manufacturing, process control systems, and clinical data management. The company provides expertise in areas such as supplier quality, regulatory affairs, clinical project management, and data programming, serving clients in highly regulated industries, including medical devices and pharmaceuticals, as indicated by references to ISO 13485 and 21 CFR 820 compliance. cGxPServe generates revenue through professional services and staffing solutions, supporting roles like manufacturing engineers, clinical data managers, and regulatory specialists. With locations in California and North Carolina, the company is positioned to address complex compliance and operational needs for clients. Its history and growth reflect a commitment to supporting quality and regulatory standards in life sciences and advanced manufacturing.
How to land this job
Position your resume to highlight leadership in managing DHF structure and sustaining engineering for disposable medical devices, emphasizing your experience with Class II or III products.
Focus on your expertise in supplier documentation strategies, change control management, and design history file creation, aligning with FDA and ISO 13485 standards.
Apply through multiple channels including cGxPServe's corporate career site and LinkedIn to maximize your visibility and application reach.
Connect with engineering and quality assurance professionals at cGxPServe on LinkedIn; start conversations by referencing recent company projects or asking about best practices in managing design controls or supplier relations.
Optimize your resume for ATS by incorporating keywords like 'design controls,' 'change management,' 'supplier relations,' 'ISO 13485,' 'risk management,' and 'design history files' to ensure it passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application platforms, and find relevant LinkedIn contacts, allowing you to focus on interview preparation and networking.
Jennie Johnson works for you!
Here’s what we do to make sure you’re successful:
Targeted Resume Revamp:
We expertly craft your resume to navigate Applicant Tracking Systems (ATS) and showcase your qualifications, making you stand out as a top-tier candidate.
Job Description Dissection:
Unpack the job posting with expert analysis, ensuring your application hits every key requirement.
Bespoke Cover Letter:
Capture the attention of hiring managers with a personalized cover letter that highlights how your skills align perfectly with the job's needs.
Interview Mastery:
Prepare for interviews like a pro with likely questions, strategic answers, and insightful questions for you to ask, setting you apart as an informed candidate.
Direct Application Insights:
Receive tailored advice on the best places to apply, ensuring your applications are seen by the right employers.
Skills and Gaps Assessment:
Identify and close critical skills gaps to position yourself as the best-fit candidate for your ideal job.
Personalized Email Pitch:
Make a memorable first impression with an email template crafted to engage potential employers and initiate meaningful conversations.
In-depth Research Guide:
Leverage comprehensive research tools to gather effective insights on companies, industry trends, and role-specific challenges.
Detailed Company Analysis:
Gain in-depth understanding of your prospective employer, giving you the edge in applications and interviews.
Strategic Candidate Overview:
Understand your unique value and why companies would want to interview you, highlighting your background and positioning.