A regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patients’ own skin to create Spray-On Skin cells.
We believe that patients are at the heart of everything we do, our employees are the lifeblood, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.
Position Summary:
The senior manufacturing engineer is a technical resource for manufacturing of products and as an interface with contract manufacturers and suppliers. The position assures product control documents are current and properly implemented at suppliers. Designs and recommends processes and equipment for efficient and appropriate manufacturing.
Key Responsibilities:
• Technical and engineering resource to the production of product and components from receipt through final inspection.
• Process development and validation
• Tooling and equipment
• Engineering and production documentation
• Ensure product is manufactured in accordance with engineering best practices, quality system, international standards and regulations, and specific requirements.
• Troubleshooting and problem solving, including root cause analysis.
• Implement corrective and preventive actions for production non-conformances.
• Continuous process monitoring, evaluation, and improvement for quality, efficiency, and costs.
• Use Document Control system to keep production documentation current and accurate.
• Support concurrent engineering efforts by participating in design development projects.
• Design, document, and implement methods for process control, process improvement, testing, and inspection.
• Lead Design and Tech transfer projects for product and process changes, including qualifying alternate suppliers.
• Participate in change control, material review boards, quality system reviews as the engineering representative.
• Evaluate current and prospective suppliers and establish requirements.
• Other duties as assigned
Job Requirements:
• Engineering degree and 8 years of relevant work experience
• Medical Device Sterile Packaging and Sterilization experience
• Proven success in working with and improving medical device operations. Knowledge of both FDA QSR and ISO standards. Demonstrated knowledge in product validation and introduction.
• Competence in engineering skills set (CAD, drawings, manufacturing systems).
• Ability to analyze data, identify additional needed information, determine root cause, and offer solutions to problems.
• Attention to details and all aspects of medical device quality.
• Proficient in communication and working with teams that consist of diverse personnel and scattered locations.
EEOC: Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.
Your Physical Work Environment Will Require: The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and/or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination is necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus. The individual is frequently required to reach with hands and arms, and repetitive motion, The individual is occasionally required to stoop, kneel, or crouch. The individual may occasionally lift and/or move up to 25 pounds.
E-Verify participant.
Information Security Compliance
Recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. Committed to protecting the security of its information and information systems. As such, each role l must demonstrate the same commitment to information security.
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