Sterilmed, a part of the CSS Group, member of the Johnson and Johnson Family of companies is currently recruiting for a Process Development Manager for their Plymouth, Mn. Facility.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed.
Sterilmed, a member of Johnson & Johnson's Family of Companies, is a nationally recognized company that safely reprocesses single-use medical devices for hospitals and surgery centers across the country. We take great pride in saving hundreds of millions of dollars for the healthcare system while simultaneously diverting thousands of tons of biomedical waste from landfills. Medical device reprocessing is an FDA-regulated industry and is endorsed by the AHA, AORN, CMS and the Joint Commission.
The Process Engineering Manager will lead a team of engineers to provide leadership and direction for sustaining engineering activities. This is an exciting new role for the company with the opportunity to drive innovation and cost savings. Partners with manufacturing and quality in the identification, definition, and execution of projects and delivers technical requirements for the launch of products as well as continuous improvement of the product's supply chain capabilities. Encourages and supports the identification and development of innovative solutions to problems and opportunities.
Essential Job Duties and Responsibilities:
Oversees technical execution of projects.
Provides comprehensive technical advice.
Facilitates resolution of complex technical and operational problems.
Promotes innovation initiatives for new products and ideas.
Reviews and approves technical documentation to verify compliance to technical specifications and standards.
Communicates with internal (manufacturing, quality, engineering) and external partners to coordinate and execute project plans.
Assigns tasks according to projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.
Ensures implementation of multiple new product development plans and programs for the business unit.
Monitors smooth execution of plans and programs at lower levels and cross functionally.
Allocates proper level of resources to facilitate attainment of project goals within established timelines and budgets.
Ensures departmental and company compliance with all local government and company regulations, policies and procedures for health, safety and environmental compliance.
Lead communication meetings to help identify and propose sustaining engineering project priorities -- based on market, technical and financial attractiveness.
Direct supervision. Manage/lead the Sustaining Engineering team consisting of Mfg Engineering/Process Engineers and/or Engineering Technicians (including contractors).
- Team responsible for managing the design, implementation, and qualification (IQOQPQ) of manufacturing equipment.
- Responsible for working with Steris (our strategic partner who manages our production facilities) to ensure their inputs are included in the new product development process in order to ensure a smooth transition from Engineering to Production.
- Provide leadership to the engineering teams creating an atmosphere for creative thinking, team unity, and accountability for delivering results.
- Readily communicate any risks, challenges, or concerns on any new product project to senior management.
- Track and improve key manufacturing metrics including cycle time, yield, throughput, etc.
- Recommend manufacturing cost savings initiatives
- Train, mentor, and develop staff. Provide on-going constructive feedback & coaching to team members to help develop their skills and to create a culture of continuous improvement
- Review and approve documents.
- Hands on execution of process development deliverables.
- Other responsibilities may be assigned & not all responsibilities listed may be assigned
POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures and assure that direct reports know & follow Sterilmed policies & procedures related to work activities performed in area of responsibility
TRAINING: Complete training in area of responsibility and assure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety
SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal.
- Bachelor’s degree in Mechanical or Biomedical engineering or equivalent engineering degree is required.
- A minimum of 6 years increasingly responsible engineering leadership experience is required.
- Experience in management and developing individuals is required.
- Prior experience in the medical device industry preferred
- Project Management Professional (PMP) Certification is desirable
- Experience in leading/managing projects requiring process & packaging validation is required sterilization verification & validation is preferred
- Experience with regulatory and industry standards such as FDA QSR 21 CFR Part 820 and ISO 13485 is preferred
- Deep knowledge and understanding of clinical application of catheter and OR surgical devices and an understanding of their manufacturing requirements preferred.
- Proficient in Microsoft Office and Microsoft Project to manage project schedules and resource utilization is required.
- Good planning, multi-tasking, and project management skills is required.
- Demonstrated track record of completing projects on time and accomplishing goals is required.
- Analytical, results oriented, self-starter, organized, ability to meet deadlines
- Be self-directed and motivated
- Take initiative to identify and anticipate needs and make recommendations for implementation
- Ability to develop strong trusting relationships in order to gain support and achieve results
- Ability to function independently as well as part of a team
- Excellent written and oral communication skills
- Ability to manage multiple priorities in fast-paced environment
Sterilmed, Inc. (6215)Job Function
Process EngineeringRequisition ID
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