Design Controls Systems Engineer

Amick Brown is seeking an experienced

• Joining our clients means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
• We are seeking a Design Controls Systems Engineer to support the our clients team focused on new product development tools and process.
• The Design Controls Systems Engineer will help plan, define, develop, verify, and deploy new engineering tools (for internal use) in compliance with established Design Control DOPs and associated processes.
• The ideal candidate is a quality-focused self-starter, with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time.
• The candidate must have a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools.
• The responsibilities of the position include:
• Delivery of training and driving adoption of Design Control processes and tools across the company
• Design Control process improvements and optimization
• Works with cross-functional teams to solve problems and execute improved tools and processes
• Enterprise wide tools planning, development, verification, and support
• Configuration and administration of corporate Design Controls tools
• Assisting with the strategy and architecture for medical device documentation including optimization for automation
• User support for complex traceability reports for regulatory submissions
• Developing templates and optimized workflows which improve product development productivity
• Ensuring compliance with global medical device deliverables including submissions, DHF, and DHR.
• Integrating Risk based approaches to Design Control

• Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
• Experience with using Application Lifecycle Management (ALM) Tools such as Polarion, MKS/PTC Integiry, Doors, HP ALM
• Strong communicator with experience in training end users including developing training content and addressing user support questions
• Database architecture and design strategy
• Requirements Management excellence including training others how to translate technical details into unambiguous, testable, reusable requirements and specifications
• Strong knowledge of Part 11 compliance for electronic signature and digital records preferred
• Understanding of multiple technology areas (software, mechanical, electrical, biomedical, clinical, robotics, test automation, etc)
• Ability to help end users from cross functional teams to efficiently create fully documented, robust, and reliable medical devices
• Detail-oriented and Quality focused with excellent investigative skills

• Bachelor’s Degree required. Master’s degree preferred.
• 3+ years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation
• Experience with Application Lifecycle Management tools (Siemens Polarion, PTC Integrity, Doors) preferred
• Additional specialized training in a discipline such as software engineering, test engineering, quality, risk management, or regulatory compliance.
• Software script writing (Python, Javascript, SQL, C) highly desirable
• Excellent verbal and written communication skills
• Excellent planning and time management skills
• Highly proficient in Word, Excel, Visio, and PowerPoint
• Video training experience desirable
• Proficiency in Oracle/Agile helpful
• The above statements are intended to describe the general nature and level of work being performed by people assigned to this job.
• They are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
• We are an AA/EEO/Veterans/Disabled employer.
• We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

• Health
• Vision
• Dental
• 401k with company match
• Paid time off
• Sick Leave
• Short-Term Disability
• Life Insurance
• Wellness & Discount Programs