Job Responsibilities:
Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.
The ability to create, support, review chemistry, manufacturing, and controls device submissions
Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed
Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)
Leads component qualifications, design validation, design verification, drug stability and process validation
Leads product investigations
Ability to make and present risked based decisions
Assess product changes against product design
Supports translation of design inputs into manufacturing control plans
Develop and implement procedures to comply with corporate and industry standards.
Coordinates and/or directs all aspects of product development activity related to a product line
Leads development of risk assessments and test methods
Quality engineering representation on Product Development and Design Review teams
Prepare and present project updates and technical discussions
Participate in project planning, budgeting, scheduling, and tracking
Support internal and external supplier audits
Provide support to the regulatory department in writing technical submissions
Complies with company procedures and policies, government regulations
Actively participates in training and providing input to training of employees on division procedures and policies
Ability to travel for business, project, and issues approximately up to 25% of time.
Other duties and projects, as assigned
Required Education and Experience:
BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
Extensive proven understanding of design controls in development stage
Pharmaceutical or combination product experience
Required Qualifications:
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
Ability to lead creation of risk management files
Ability to develop solutions with business impact
Advanced statistical and risk assessment techniques
Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
Ability to make and present risk-based decisions
Strong interpersonal skills
Ability to analyze and optimize manufacturing and quality systems
Product, design & prototyping
Ability to create and provide training
Problem solving ability
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
Ability to lead cross functional teams
Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines