Lead Engineer jobs in United States, Pennsylvania, State College

Key Responsibilities:

• Lead cross-functional efforts to transfer manufacturing processes and products between sites.
• Develop and execute validation plans, process documentation, and training materials.
• Collaborate with design, quality, planning, purchasing and operations teams to ensure compliance with regulatory standards.
• Leverage data to identify and implement process improvements to enhance efficiency and product quality.
• Serve as a technical liaison between various teams, providing hands-on support and troubleshooting.
• Lead root cause analysis and implement corrective and preventive actions (CAPA) for process-related issues.
• Monitor key process metrics and drive improvements in yield, cycle time, and cost.
• Travel domestically and internationally to support transfer activities and build strong site relationships.

Qualifications:

• Bachelor’s degree in an Engineering discipline from an accredited university (Mechanical, Electrical, Industrial, or related).
• Minimum of 5 years of experience in manufacturing or a regulated industry (e.g., medical devices, aerospace, automotive).
• Proven ability to communicate effectively across technical and non-technical audiences.
• Demonstrated self-motivation and ability to work independently with minimal supervision.
• Strong problem-solving skills and attention to detail.
• Interest in professional development and future leadership opportunities.
• Must possess a valid Passport

Preferred Qualifications:

• Experience with medical device manufacturing or ultrasound technology.
• Familiarity with regulatory standards such as ISO and FDA.
• Project management experience in cross-site or international environments.
• Familiarity with ERP and MES systems.
• Experience with Solidworks or equivalent design software.

• Understand, monitor and improve manufacturing process capabilities

• Leverage data acquisition, management and processing systems to focus improvement efforts to improve efficiency and reduce cost

• Help to advance companies effort to incorporate contemporary manufacturing technologies

• Identify opportunities to improve efficiency through the use of automation where appropriate

• Formally document new part designs, fixture designs and manufacturing procedures according to internal and external requirements

• Respond when needed to manufacturing emergencies to quickly identify and remediate issues

• Work with design teams, quality assurance, planning, manufacturing, purchasing, and suppliers to understand cause and implement solutions

• Formal and timely communication to the management team on project status

• Create, edit and approve engineering changes, work instructions, deviations, and other documentation as required

• Bachelors Degree in Engineering or related discipline (Mechanical Engineering Preferred)

• 1 year, or equivalent Internships ofpractical experience in a manufacturing environment

• Must have basic understanding of Solidworks or equivalent design software

• Statistically sound data analysis abilities to describe, diagnose, predict outcomes and prescribe solutions

• Demonstrated ability to document user level instruction and train others to execute the instructions.

• Understanding of a structured approach when analyzing and evaluating alternatives to manufacturing issues.

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

• Must be able to communicate and interact successfully with peers and leadership.

• Must have the ability to generate written communication that is clear and concise, to lead a discussion among colleagues as well as provide formal presentations to management.

• Must be able to workindependently/self-motivated.
  Experience with and knowledge of process automation including robotics and coordinate systems

• A proven track record working with cross-functional development teams.

A typical day consists of assisting customers and performing transactions. You will also look for opportunities to make customers lives easier by setting up self-service options and building relationships. Throughout the week, you will schedule time to review branch operations and share updated policy and procedures with branch employees. This results in the business is adhering to control expectations.

Roles and Responsibilities

• Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with regulatory standards.

• Conduct thorough inspections and audits of manufacturing processes to identify areas for improvement and ensure product quality.
• Collaborate with cross-functional teams, including R&D, production, and regulatory affairs, to support product development and production transfer activities.
• Ensure that design controls are effectively applied throughout the product lifecycle, from concept to commercialization.
• Manage Design and Production transfer activities.
• Investigate and resolve quality issues, including non-conformances and customer complaints, using root cause analysis and corrective/preventive actions.
• Prepare and maintain detailed documentation, including quality plans, inspection reports, and validation protocols.
• Stay up-to-date with industry regulations and standards, and ensure that the company remains compliant with all relevant requirements.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

• Bachelor's Degree or a minimum of 7 years' work experience
• Minimum of 3 years of experience in a regulated industry, preferably within the medical device industry.
• In-depth knowledge of design controls and production transfers.
• Strong analytical and problem-solving skills, with the ability to identify and address quality issues effectively.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Detail-oriented and highly organized, with the ability to manage multiple projects simultaneously.

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Roles and Responsibilities

• Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with regulatory standards.

• Conduct thorough inspections and audits of manufacturing processes to identify areas for improvement and ensure product quality.
• Collaborate with cross-functional teams, including R&D, production, and regulatory affairs, to support product development and production transfer activities.
• Ensure that design controls are effectively applied throughout the product lifecycle, from concept to commercialization.
• Manage Design and Production transfer activities.
• Investigate and resolve quality issues, including non-conformances and customer complaints, using root cause analysis andcorrective/preventiveactions.
• Prepare and maintain detailed documentation, including quality plans, inspection reports, and validation protocols.
• Stay up-to-date with industry regulations and standards, and ensure that the company remains compliant with all relevant requirements.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

• Bachelor's Degree or a minimum of 7 years' work experience
• Minimum of 3 years of experience in a regulated industry, preferably within the medical device industry.
• In-depth knowledge of design controls and production transfers.
• Strong analytical and problem-solving skills, with the ability to identify and address quality issues effectively.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Detail-oriented and highly organized, with the ability to manage multiple projects simultaneously.

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.