Production Operator jobs in United States, Pennsylvania, West Whiteland Township

Your role:

• Developing and executing the regulatory strategy for new product development, design changes and field safety corrections for US, EU, Canada and RoW.
• Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development.
• Responsible for product registrations/approvals for their responsible products within IGT-S portfolio.
• Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process.
• Review and validate labelling, marketing materials, claims substantiation evidence, clinical protocols to maintain compliance with global requirements.
• Keep abreast of current regulatory procedures and changes.
• Provide critical input and guidance on regulatory change assessments, risk assessments and regulatory requirements implementation.
• Participate in internal audits and play a key role in (external) audits, related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
• Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
• Identify areas for improvement in terms of efficiency and compliance for internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead and/or participate in process improvement teams to affect local or cross-business unit changes.
• Provide strategic guidance, mentor and coach the RA resources and project team by being a Regulatory subject matter expert.
• Establishes operational objectives and work plans.
• Work according to the business applicable processes and as ambassador of the Philips values.

(4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required)
2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation
3. Education- Bachelors/Master of Science degree
4. Anything else-

Project planning and management skills (preferred)

Excellent verbal, written communication skills (English) & interpersonal skills.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Production Planner – Reedsville, PA

As a Production Planner, you will create and manage production schedules, materials planning, and inventory buffers to ensure on-time delivery of customer orders while optimizing workforce and equipment utilization. This role operates in a dynamic manufacturing environment on a 2:30 pm – 10:30 pm shift, Monday through Friday.

Your role:

• Ensure timely delivery of customer orders by aligning production schedules and material availability.

• Maintain high-quality planning master data in collaboration with Enterprise Information Management (EIM).

• Develop a feasible Master Production Schedule (MPS) from initial supply plans.

• Create a Detailed Production Schedule (DPS) that minimizes changeover times and supports efficient operations.

• Optimize workforce and equipment utilization across production activities.

• Generate and manage the Material Requirements Plan (MRP) with support from Operational Buyers.

• Oversee buffer and supermarket stock levels using Demand Driven MRP (DDMRP) principles.

• Lead daily and weekly planning meetings with Production and Operations teams to ensure alignment and execution.

You're the right fit if:

• You’ve acquired at least 2 years of experience in a production plant, manufacturing site, or equivalent environment.

• Your skills include production planning, ERP systems (SAP preferred), and strong computer and reporting capabilities.

• You have a High School Diploma, vocational training, or equivalent education.

• You’re an effective communicator, highly organized, and bring practical knowledge of Lean manufacturing tools (bonus if you’ve applied them directly).

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

How we work together

This is an onsite role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .

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The pay range for this position in Reedsville, PA is $28 to $35 an hour.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance toReedsville, PA

Production Manager - Reedsville, PA - This role will require a 6-month training period in Bothell, WA.

You will manage a team of production workers, a production unit or production process and take responsibility for the production KPIs.

Your role:

• This position will oversee the production systems manufacturing team in Reedsville facility, this process will be transferred from Bothell to RDS, as part of the Samba project
• Production supervisor, production workers and production technicians will be reporting to this person, the position will need to work with different stakeholders such as engineers, warehouses employees, buyers, supplier quality engineers, quality engineers.
• You will develop problem solving skills to overcome different production situations, he/she will work with other production areas in RDS and SHA to develop good manufacturing/lean practices.

You're the right fit if:

• You’ve acquired 5+ years of experience in… industrial/ manufacturing engineering/ supply chain leading role with a bachelor's degree or 3+ years of experience with a master's degree.
• Your skills include… problem solving, conducts complex analyses of production and process data, lean knowledge, strong attention to product and process quality, team performance management
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together

This is an office role (5 days per week)

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

The pay range for this position in Reedsville, PA is $116,625 to $186,600.

.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

This is a 1st shift role with the hours of 6:30am to 2:30pm.

This is a 2nd shift role with the hours of 2:30pm to 10:30pm.