Job Summary:

In this role, the individual will be responsible for applying the principles and theories of science, engineering, and mathematics to solve technical problems in manufacturing, facilities, and research and development

Responsibilities (Essential Duties and Responsibilities):

• Maintain all production and research equipment in an operational and calibrated state.
• Perform or arrange maintenance and calibration activities on production and research equipment.
• Coordinate activities with our landlord or third-party vendors to maintain the building and associated support systems.
• Create and maintain preventive maintenance, calibration and operational procedures for equipment
• Help develop and implement safety practices used in the prevention, control, or remediation of hazards.
• Support scaling of manufacturing processes by installing and qualifying systems and equipment.
• Comply with FDA Good Manufacturing Practice guidelines

Responsibilities (Non-Essential Duties and Responsibilities):

• Assist with the installation and implementation of new capital equipment

Minimum Required Qualifications (Knowledge, Skills, and Abilities):

• A High School Diploma/GED
• A degree in Engineering Technology and at least 3-years relevant experience or at least 5-years relevant experience with no degree
• Mechanical aptitude and competency maintaining various types of electro-mechanical equipment
• The ability to communicate effectively, both verbally and in writing
• The ability to read, understand and perform technical procedures written in the English language
• Attention to detail and the ability to complete the paperwork required for medical device manufacturing
• Confidence and autonomy where they can self-manage their work

Preferred Qualifications (Knowledge, Skills, and Abilities):

• Experience with Computerized Maintenance Management Systems (CMMS)
• Experience working in cleanrooms
• Experience in the medical device industry working with Good Manufacturing Practices (GMP)
• Familiarity with FDA regulations, ISO standards, and Quality Management Systems

Language Skills:

• Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

Work Environment:

• The individual will split time between a normal, environmentally controlled office environment, an environmentally controlled cleanroom environment, and a warehouse environment.

Physical Demands:

• The individual will be expected to perform physical activities involving bending, lifting, pulling, and pushing.
• Manual dexterity is required for the handling of small parts, wires, and plumbing fixtures.
• Some standard office work, which involves writing, typing, filing, and other work performed at a desk or in a normal office environment.
• Moves boxes weighing up to 50 pounds.

Job Summary:

In this role, the Manufacturing Manager will lead all aspects of the production of medical devices and other materials sold by Viscus Biologics. This critical role involves managing a team of skilled professionals, ensuring regulatory compliance, maintaining strict quality control, optimizing manufacturing processes, and meeting production goals.

Responsibilities (Essential Duties and Responsibilities):

• Develop and execute production plans to meet customer order delivery and internal inventory requirements. Communicate production schedules and progress against the schedules to senior management and to customers.
• Promote and enforce a safe working environment by adhering to OSHA regulations and company safety policies. Conduct safety training and ensure proper safety equipment and practices are followed.
• Ensure the timely and efficient supply of raw materials and components required to meet production and cost objectives.
• Manage the planning, preparation, and shipment of customer orders to achieve on-time delivery objectives.
• Manage and allocate human and material resources efficiently to optimize production efficiency. Monitor and control production costs while staying within budget constraints.
• Recruit, train, and supervise production and warehouse staff. Provide guidance, mentorship, and performance feedback to ensure a skilled and motivated workforce.
• Develop and maintain a structured training program for staff and career pathways to promote career growth and retention.
• Continuously identify opportunities for process optimization, cost reduction, and waste reduction. Implement lean manufacturing principles and Six Sigma methodologies to streamline operations.
• Work in conjunction with the Quality department to implement and maintain quality control processes to adhere to FDA and other relevant regulatory standards. Oversee the implementation and adherence of Good Manufacturing Practices (GMP) and ISO standards. Conduct audits and inspections to ensure compliance and address any quality issues promptly.
• Identify capital equipment needs and solutions, working with the accounting department to perform cost-benefit analysis to justify procurement. Manage the process of procurement and implementation into the production workflow.
• Participate in company budgeting activities.
• Stay informed about industry trends, technological advancements, and best practices in medical device manufacturing. Attend workshops, conferences and training programs to enhance skills and knowledge.

Responsibilities (Non-Essential Duties and Responsibilities):

• Maintain accurate inventory records in the Enterprise Resource Planning (ERP) system. Maintain lot traceability of materials to meet regulatory requirements. Implement inventory control measures to minimize stockouts and excess inventory.
• Generate regular reports on production metrics, quality, and performance for senior management and regulatory agencies. Maintain accurate production records, including device history records and batch records.

Minimum Required Qualifications (Knowledge, Skills, and Abilities):

• Bachelor’s degree in an Engineering field.
• At least 3 years of experience working in manufacturing in a regulated environment
• Demonstrated leadership capabilities, including supervising cross-functional teams, training team members, and driving and communicating results.
• Proficiency in using ERP systems for production planning, purchasing, and inventory management.
• Thorough understanding of health and safety regulations.
• Expert knowledge of Microsoft Office products (Word, Excel, and PowerPoint).
• Ability to work under pressure and meet strict deadlines.
• Strong organizational skills and attention to detail. Must be able to manage time and efficiently transact business in a fast-paced environment.
• Effective business writing skills
• First class communication and interpersonal skills. Must be able to work effectively with people at all levels of the organization.

Preferred Qualifications (Knowledge, Skills, and Abilities):

• A demonstrated track record of progressive roles within a manufacturing environment
• Experience in the medical device industry working with Good Manufacturing Practices (GMP)
• Familiarity with FDA regulations, ISO standards, and Quality Management Systems

Language Skills:

• Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

Work Environment:

• The individual will split time between a normal, environmentally controlled office environment, an environmentally controlled cleanroom environment, and a warehouse environment.

Physical Demands:

• The individual will be expected to perform standard office work, which involves writing, typing, filing, and other work performed at a desk or in a normal office environment.
• Prolonged periods of sitting at a desk and working on a computer.
• Moves boxes weighing up to 30 pounds on occasion.

Job Summary:

In this role, the individual is primarily responsible for performing activities in support of the development and manufacture of tissue and polymer based medical devices based on proven scientific concepts.

Responsibilities and Duties:

• Interpret customer and market needs into documented product requirements
• Refine product and process characteristics through research and experimentation
• Evaluate product risks using traditional methods and implement control mechanisms to reduce risks to acceptable levels.
• Create product specifications, raw material specifications, and manufacturing procedures.
• Demonstrate the ability of products to meet requirements through verification and validation testing.
• Become familiar with and follow design control procedures according to FDA and ISO requirements.
• Plan and manage project work in accordance with defined deliverable targets.
• Support regulatory product submissions through testing and documentation.
• Specify materials and equipment required to achieve objectives.
• Identify and direct work with outside strategic partners as required.
• Research scientific and clinical publications to support methods or conclusions
• Generate technical reports, making data-based recommendations for the products.
• CAD design of product, tooling and fixtures as required
• Comply with regulatory guidelines for design control

Qualifications (Knowledge, Skills, and Abilities):

• A Bachelor's degree in Engineering or a related field is required.
• Undergraduate experience with tissue engineering and/or polymer science is preferred, however any prior experience with medical devices is desirable.
• Experience working in cleanroom environments is highly desirable.
• Strong written and verbal communication skills, with the ability to work closely with both internal and external team members.
• Proficient in the use of personal computers, including the use of Microsoft Outlook, Microsoft Word and Microsoft Excel.
• The ability to make necessary decisions and/or take action required to carry out job duties.
• The ability to operate independently and to self-manage all activities in working towards the common goals of the organization.

 Language Skills:

• Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

Work Environment:

The individual will split time between a typical office environment and the manufacturing area, which consists of a mix of cleanroom and lab­ style manufacturing spaces. When in the cleanroom, the individual will be expected to wear designated gowning and follow standard anti­ contamination practices. All areas are environmentally controlled.

Physical Demands:

The individual will be expected to perform standard office work, which involves writing, typing, filing and other work performed at a desk or in a normal office environment.

Additionally, the individual will be expected to perform lab and manufacturing work, which involves taking measurements using hand­ held and large computer-controlled tools, measuring and mixing chemicals, and operating large pieces of laboratory and manufacturing equipment.