Product Improvement Engineer

---

Job description

ESSENTIAL JOB RESPONSIBILITIES :

• In depth understanding and experience with consumables/process change qualification and implementation/documentation.
• Writing verification and validation protocols.
• Engage in risk analysis/assessment for improvement/sustaining projects or consumables qualifications
• Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility.
• Assist in failure investigations and root cause analyses as they relate to assay or parts/consumables qualification.
• Partner effectively with functional representatives from Regulatory, Production, Quality, and other relevant departments.
• Have demonstrated biology laboratory skills, including pipetting.
• Have demonstrated engineering laboratory skills.
• Have knowledge and experience in design control processes, experimental design, and data analysis.
• Support evaluation of potential mitigations and corrective actions
• Contribute to final report for each project

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time

MINIMAL Requirements:

Education and Experience (in years):

• Bachelor’s degree with 3-4 years of related work experience OR
• Master’s degree in field with 1-2 years of related work experience.

Knowledge and skills:

• Must have experience with automation lines and developing process documentation or study plans.
• Experience with failure investigations and root cause failure analysis.
• Proficiency with Microsoft Office Suite.
• Excellent communication, writing, and documentation skills.
• Ability to handle multiple projects simultaneously.
• Ability to work independently and in a team setting; able to work cross-functionally.
• Basic statistical skills

P hysical Requirements/abilities:

• Ability to work in an office and lab environment (BSL2 setting)
• Occasional lifting (10-20 lbs)

PREFERRED REQUIREMENTS:

• Industry experience in high volume manufacturing in medical device consumables.
• Experience working on the development of diagnostic devices under design control processes is highly desirable.
• Experience in problem solving methods, root cause analysis, critical thinking
• Experience working with biological samples in a medical device development environment is a plus.
• Knowledge of real-time Polymerase Chain Reaction (rt-PCR) or other biological applications of fluorescence-based techniques is a plus.
• Experience in clean room or biosafety environment with controlled gowning procedures.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.