Manufacturing Engineer 2

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

Position Summary

The Manufacturing Engineer II is responsible for providing engineering support to existing products as well as process development for new products. 

Responsibilities and Duties

• Collaborate with Production to provide sustaining support in resolving product/process problems in a clean environment room.
• Responsible for tasks involving designing, developing, testing and implementing processes, tooling, and fixtures for commercial product.
• Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
• Contribute to the development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and other documentation.
• Support efforts to resolve quality related events (NCMR, CAPA, Audit Finding) using hands-on investigation and root cause analysis.  
• Create and release label files used for printing product labels.
• Generate and execute test plans, verification, and process validation protocols and reports.
• Other duties as assigned.

Requirements

• Bachelor/Master of Science degree in Engineering with a minimum of 2 years of experience in medical device industry.
• Understanding medical device processes and assembly knowledge to drive product yield and performance.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Familiar with Medical Device Design Controls.
• Experience with Process Validation of Medical Devices (IQ-OQ-PQ).
• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOEs, GR&R) and familiar with statistical software (JMP, MiniTab) a plus.
• Ability to create and maintain drawings using CAD (SolidWorks).
• Excellent oral and written communication skills.
• Self-motivated, action oriented and result oriented.

Salary: $118,000 - $134,000 (Annual Base Salary)

Actual compensation will be determined based on factors including geographic location, relevant experience, education, skills, qualifications, internal equity, and business considerations. Placement within the salary range will depend on the successful candidate's knowledge, experience, and demonstrated capabilities.

In addition to base salary, eligible employees may participate in annual incentive programs and receive a comprehensive benefits package that includes:

• Medical, dental, and vision coverage
• 401(k) plan with company match
• Paid time off and company holidays
• Annual and Long Term Incentive Programs
• Wellness programs and employee assistance resources
• Additional health, financial, and work-life benefits

This compensation information is provided in accordance with applicable state and local pay transparency laws.

Overtime Eligibility

Non-exempt employees are eligible for overtime pay in accordance with applicable laws. Occasional overtime may be required to support business objectives and customer commitments. Any voluntary overtime must be approved in advance by the employee's supervisor.

This role is not available for any form of immigration sponsorship or support, including completion of the Form I-983 training plan required for STEM OPT. 

To learn more about life at Recor and explore current opportunities, visit RecorMedical.com/careers.

Equal Employment Opportunity

At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Recor also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email [email protected]

Job Description Disclaimer
This job description is intended to provide a general overview of the position and is not an exhaustive list of all duties, responsibilities, qualifications, or working conditions associated with the role. Responsibilities may be modified, expanded, or assigned as necessary to meet business needs.

Pre-Employment Requirements

At Recor Medical, patient safety, integrity, and regulatory compliance are foundational to everything we do. To support these standards, employment is contingent upon meeting the following requirements:

• Background Screening & Drug Testing: Final candidates may be required to successfully complete a background check and/or drug screening, conducted in accordance with applicable laws and regulations.
• Washington Fair Chance Act Compliance (if applicable): For applicants who reside in or are applying for roles based in Washington State, Recor Medical adheres to the Washington Fair Chance Act. This means we do not inquire about or consider criminal history until after an initial determination has been made that the candidate is otherwise qualified for the role, and we do not automatically exclude individuals based on criminal records. 
• New Hire Training: All employees are required to successfully complete Recor training program within their first 90 days of employment as a condition of continued employment.
• California Fair Chance Act: Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Recruitment Fraud Warning

Recor Medical does not request payment, banking information, or fees from job applicants at any stage of the recruitment process. We also do not conduct interviews exclusively through text message or chat platforms.

All legitimate employment opportunities are posted on our official Careers page at RecorMedical.com/careers.

If you receive a suspicious communication claiming to represent Recor Medical, please report it to [email protected]. If you have shared personal information with a suspected scammer, please contact your local authorities immediately.

Radiation Safety Requirement

Certain field-based roles at Recor Medical require work in environments where radiation sources (e.g., x-ray equipment) are in use. Employees in these roles will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. This program is designed to ensure compliance with federal and state regulations and to maintain radiation exposure at levels that are As Low As Reasonably Achievable (ALARA). Additional guidance and protective equipment, as necessary, will be provided as part of onboarding and ongoing safety training.

Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.