Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
- Collaborate closely with I&D PMO and project leads to bring products to market
- Ensure compliance to QMS and design control processes and procedures
- Facilitate and support risk management activities such as FMEA and risk management
- Work in a cross-functional, collaborative, team-based environment
- Anticipate roadblocks, provide direction for navigating the quality system and supporting applications
- Take an active role in Design Reviews to assess technical and compliance questions
- Ensures that device labeling designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations
- Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
- Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
- Provides work direction to engineering support staff.
- Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
- Follows department processes and regularly makes recommendations on these processes.
- Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
- Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
- Analyzes data and presents it in appropriate forums.
- Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentatio
- Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
- Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
- Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
- Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
- Understanding of and adherence to GMP practices and FDA regulations.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires travel based on business needs.