Senior Engineer, Packaging

Olympus Corporation of the Americas; Brooklyn Park (MN); On-site; USD 96,000 - 129,000; Full time

Benefits offered by this job

Competitive salaries, annual bonus and

401(k) with company match

24/7 Employee Assistance Program

Wellbeing Programs (live and on-demand

Paid Vacation and Sick Time

Parental Leave and Adoption Support

12 Paid Holidays

On-Site Child Daycare, Café, Fitness

Job summary

Olympus Corporation of the Americas in Brooklyn Park, MN, is seeking an experienced packaging engineer to lead the design, development, and validation of medical device packaging systems. You will collaborate with R&D, Quality, Manufacturing, and suppliers to create compliant, scalable solutions and drive cost-saving improvements.

The role emphasizes ISO 11607-1/2 knowledge, design verification and process validation, and mentoring operators on new packaging processes across multiple projects.

Qualifications

• Bachelors of Science degree in science, engineering or technology discipline.
• Minimum of 5 years of professional experience within the medical device industry supporting packaging is required.
• Experience with packaging design and process development across an organization.
• Experience in integrated cross-functional product development teams.
• Knowledge of ISO 11607-1/2 and how it guides packaging requirements.

Responsibilities

• Plan and execute key packaging engineering assignments for operations, manufacturing, and sustaining activities.
• Lead packaging projects for process development, cost savings, and innovative design.
• Coordinate testing to ensure package integrity from design to end-user.
• Lead troubleshooting of packaging issues in design, manufacturing, and field.
• Drive packaging improvements and lead implementation activities.
• Ensure compliance with government and corporate guidelines.
• Develop packaging design requirements and verification/validation docs.
• Provide training on new packaging designs and processes.

Skills

Packaging design

Process development

Cross-functional collaboration

Project leadership

Testing & validation

Technical writing

ISO 13485 knowledge

Education

Bachelor of Science in science/engineering/technology

5+ years medical device packaging experience

Tools

ISO 11607-1/2

Job description

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Workplace Flexibility:Onsite

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Provide technical leadership and engineering support for the design, development, validation, implementation, and continuous improvement of released medical device packaging systems and processes. Serve as the packaging subject matter expert, driving process development, cost-reduction initiatives, and operational improvements through packaging design optimization, material selection, and manufacturing efficiency enhancements. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Operations, Supply Chain, Regulatory Affairs, and suppliers to develop, validate, and sustain compliant, scalable packaging solutions. Support new product introductions, process validations, testing activities, and sustaining engineering efforts while identifying opportunities to improve quality, reliability, throughput, and overall business performance.

Job Duties

• Plans and executes key package engineering assignments related to operations, manufacturing, and sustaining activities.
• Engages in and leads packaging projects related to process development, cost saving initiatives, innovative package design, equipment standardization, and test method development.
• Determines and coordinates performance and stability testing to ensure product and package integrity for design and manufacturing through the end-user.
• Leads troubleshooting efforts for the resolution of packaging related issues for design, manufacturing, and in the field.
• Drives packaging improvements for design, processing, and functional requirements and leads the implementation activities.
• Executes packaging projects and support in compliance with government and corporate guidelines.
• Participates and provides technical expertise for risk assessment and compliance assurance programs for packaging.
• Assures delivery of robust, cost-effective, and fully compliant packaging solutions that meet current and evolving customers’ needs.
• Creation of packaging design requirements; such as component prints, assembly prints, and inspection criteria.
• Capable of developing packaging processes including all elements of process validation.
• Create, review, and approve internal packaging verification and validation documentation.
• Lead continuous improvement measures by providing technical information and reviewing packaging designs and processes as they are revised.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
• Knows and follows all laws and policies that apply to one's job while maintaining the highest levels of professionalism, ethics and compliance at all times.
• All other essential duties as directed.

Job Qualifications

Required:

• Bachelors of Science degree in science, engineering or technology discipline.
• Minimum of 5 years of professional experience within the medical device industry supporting packaging is required.
• The ideal candidate should have a successful record of supporting packaging design and process development across an organization.
• Experience working in integrated cross-functional product development teams.
• In-depth knowledge of ISO 11607-1/2 and how it guides requirements for packaging design, process development, manufacturing, and testing.
• Knowledge of sterile packaging design, material characteristics, and verification/validation practices.
• Must be able to support multiple project teams simultaneously, as well as lead packaging specific projects when needed.
• Demonstrated experience in executing design verification and/or process validation of packaging in the medical device industry; including technical writing of protocols and reports.
• Experience in writing and executing design verifications and/or process validations is required.
• Knowledge of and understanding of ISO13485 and its application to medical device products.
• Experience in supplier selection/management for medical device packaging materials and equipment.
• Understanding of risk analysis and experience in the creation of design and process FMEAs.
• The candidate must be proficient with the use of Microsoft Office applications.
• Time management skills allowing for leading or working on multiple projects at once.

Preferred:

• Process development and/or manufacturing experience preferred.
• Practical application of statistical analysis and techniques, as well as Design of Experiments (DOE), is preferred.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$95,904.00-$129,470.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations:

Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park ||Research and Development