Manufacturing Engineer II
Recor Medical Europe GmbH
Summary
The Manufacturing Engineer II is responsible for providing engineering support to existing products as well as process development for new products.
Job description
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.
Requirements
- Bachelor/Master of Science degree in Engineering
- Minimum of 2 years of experience in medical device industry
- Understanding of medical device processes and assembly knowledge
- Knowledge of and compliance with Quality System requirements (QSRs, FDA, ISO, MDD, MDR)
- 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)
- Familiarity 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Company Holidays
- Annual Incentive Programs
- Long Term Incentive Programs
- Wellness Programs
- Employee Assistance Resources
Company overview
Recor Medical Europe GmbH is the European subsidiary of Recor Medical, an innovative medical technology company headquartered in Palo Alto, California, and a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd. The company specializes in transforming hypertension management through its pioneering Paradise Ultrasound Renal Denervation (uRDN) system. This minimally invasive medical device utilizes ultrasound technology to perform renal denervation, offering a non-pharmaceutical treatment option for patients with hypertension, the world's leading cardiovascular risk factor. The Paradise system has received FDA approval in the United States, bears the CE mark for European markets, and is an investigational device in Japan. With operations based in Frankfurt, Germany, Recor Medical Europe GmbH focuses on clinical adoption, market access, and commercialization efforts across Europe, the Middle East, and Africa. The company has demonstrated strong clinical evidence through multiple randomized controlled trials and continues to invest in rigorous clinical studies and high-quality product development to establish a solid foundation for widespread clinical adoption of this groundbreaking hypertension therapy.