Most recent job postings at medicaldesignandoutsourcing
via LinkedIn posted_at: 25 days agoschedule_type: Full-time
Come join Millstone Medical and become part of our dynamic organization! We Deserve the Best – And So Do You... High Growth Company Opportunity to Learn and Grow Shape your Career See the Importance of Your Work Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay, Come join Millstone Medical and become part of our dynamic organization!

We Deserve the Best – And So Do You...

High Growth Company

Opportunity to Learn and Grow

Shape your Career

See the Importance of Your Work

Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay, tuition reimbursement and voluntary benefits in addition to an employee-centric work environment.

Who are we? Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.
• **Medical Device Experience preferred, local candidates ONLY***
• **VISA SPONSORSHIP IS NOT AVAILABLE FOR THIS POSITION ***

MANUFACTURING ENGINEER

JOB SUMMARY:

Millstone is seeking an energetic and engaged Manufacturing Engineer to identify and drive continuous improvement. As our Manufacturing Engineer, you will be responsible for developing and implementing mistake-proof processes, equipment, and tooling used to execute on critical cleaning and sterile packaging of orthopedic medical devices.

Manufacturing Engineering (ME) is responsible for equipment selection, installation, validation, maintenance and calibration, improvements, documentation, spare parts, and of course Product Quality. As a Manufacturing Engineer, you will be in a position to ensure our legacy product lines are continuously improved and new product lines transition smoothly into full production, all while adhering to financial and scheduled commitments.

RESPONSIBILITIES:

· Provide technical leadership and guidance for product quality, process compliance with all applicable regulations, Millstone quality system requirements, applicable safety standards, and policies

· Oversee development and implementation of timely, economical, repeatable, validated, mistake-proof manufacturing processes and controls for new and legacy products

· Drive continuous improvement and lean manufacturing methodologies into production

· Responsible for timely equipment troubleshooting and repair, development of systems and procedures to be used for product quality and process capability improvements

· Trend preventive maintenance and calibration data for end-of-service predictions using predictive analytics

· Collaborate and partner with various departments to investigate and troubleshoot process or equipment issues, and to implement specific corrective actions using PFMEA, root cause analysis, and other risk management methodologies

· Act as an integral member of project teams tasked with resolving technical issues or continuous improvement projects

· Collaborate with program development on new product launches and product transfers to manufacturing. Develop and conduct Factory Acceptance Tests and equipment validation ensuring a high degree of process capability.

· Responsible for all necessary documentation and approvals; standard operating procedures, work instructions, and assist with related training

· Develop workable project plans and timelines to meet goals

· Develop workplan and measurement data templates within the regulatory asset manager

· All other duties as assigned

KNOWLEDGE & SKILLS:

· B.S. Degree in Engineering with 2-5 years of experience in medical device processing/manufacturing engineering/product development.

· Ability to work in a fast-paced environment with multiple priorities

· Exemplary verbal and written communication and organizational skills

· Ability to work with a team or independently with minimum supervision

· OEE, GMP Practices, lean certified, black belt in six sigma and Minitab proficiency is highly preferred

· Knowledge of, or experience with, automated systems or UV glue system is a plus

ADDITIONAL INFORMATION:

To learn more about Millstone Medical Outsourcing and all its current employment opportunities, please visit us at www.millstonemedical.com.

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws
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via LazyApply schedule_type: Full-time
VALIDATION ENGINEER Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work! Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of... medical devices. Millstone also engages in other activities, VALIDATION ENGINEER
Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!
Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of... medical devices.
Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.
What's in it for you?A company committed to quality, growth, career pathing.At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.Total Rewards Benefits Program:

Medical - Starting on the 1st day of employment
Dental - Starting on the 1st day of employment
Vision - Starting on the 1st day of employment
Supplemental Benefits - Life, Disability, Critical Illness
Paid Time Off
Tuition Reimbursement
Career Pathing
401(k) with match

To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.
Responsibilities Include:
The Packaging Engineer will support multiple concurrent projects and is responsible for packaging configurations and processes related to new product launch, existing packaging improvements, and line extensions. This includes evaluating packaging configurations for feasibility in relation to validation (ISO 11607) and commercial success during Millstone’s launch process. The Packaging Engineer will manage Millstone’s Fastlane Packaging to support new programs while continuously evaluating the Fastlane strategy to stay competitive in the industry. Additionally, this role will work cross functionally to support Millstone’s operations team with packaging related trouble shooting and cost reduction projects.
Skills/Experience Required:
o Bachelor's Degree in Packaging Technology/Engineering
o 4-6 years engineering experience
o Extensive Experience with sterile barrier packaging system designs consisting of sterile pouch and thermoformed tray packaging.
o Experience with Package Design Verification and Validation including Packaging Usability, Design Verification and Validation, Transportation and Handling testing, Package quality including sterile barrier testing (ISO 11607)
o Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards.
o Experience with Thermoforming, Heat Sealing, Impulse Sealing, Vacuum Flush Pouching, Cartoning, and label printing/ verification.
o Sterilization packaging processes such as aseptic filling and packaging for terminal sterilization using autoclave, VHP, EtO, Gamma, etc.
o Possess the ability to be actively involved in trouble-shooting packaging and process problems, coordinating with internal and external teams and resources.
o Able to guide others in the use of test equipment/tooling/processes.
o Knowledge of Minitab
o Ability to troubleshoot equipment.
o Ability to read and interpret schematics and detailed mechanical drawings.
o Ability to multi-task, detail oriented and effectively plans and manages time and deliver results on schedule.
ADDITIONAL INFORMATION:*Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
Job Type: Full-time
Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance

Experience level:

4 years
6 years

Schedule:

Monday to Friday

Work setting:

In-person
Manufacturing facility

Application Question(s):

Will you now or in the future require visa sponsorship?

Work Location: In person
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via Salary.com schedule_type: Full-time
Company Description(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.In January of 2023 LSO acquired J-Pac Medical (www.j-pacmedical.com), Company Description(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.In January of 2023 LSO acquired J-Pac Medical (www.j-pacmedical.com), a Medical Device Contract Manufacturer based out of New Hampshire to expand LSOs geographic reach in the medical device arena. Due to the recent acquisition and with over 25 years of growth, we are currently seeking a self-motivated Quality Engineer with a good positive energy to join our team at the New Hampshire Facility in Somersworth.The Quality Engineer's role is to ensure the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the... quality of manufacturing standards, and develop guidelines for technological improvement.We encourage you to submit a resume with salary requirements.Job DescriptionEssential Duties and Responsibilities include the following. NOTE: Other duties may be assigned.Develop, document, and implement QA proceduresInterpret and assess conformity to regulatory standardsProvide analytical investigations and develop root cause for non-conformancesDesign and specify gauging and test equipment for quality assuranceWrite protocols, analyze data, and generate summary reports for verifications and validationsLead and participate in design control projects for new and changing medical devicesInterface with vendors and customers as requiredParticipate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.Conduct supplier evaluations, qualifications, and quality auditsReviewing all lab results and approve product release.Working in a team environment with Quality Department and J- Pac Medical personnel.Supplier Quality Tracking (assist in Supplier Quality Audits as required)backup for inspection and test (incoming, in-process & final)Assisting/Participating in Customer Audits (as needed)QualificationsEducation and ExperienceBS or MS in Engineering, or scientific disciple with 5-7 years of experience in the manufacture of medical devices/disposables (Class II) for the medical device market3 years Medical Device industry experience preferredCertified Quality Engineer or Quality Auditor (ASQ) preferredExperience with design control, process validation, failure investigations, root cause analysis, and the application of statistics to the practice of quality assuranceExperience participating in FMEAs or other risk assessment activitiesExperience with supporting FDA and certified body auditsClean room experienceTeam player with strong communication, interpersonal, and presentation skillsAbility to read and interpret documents such as safety rules, operating and maintenance instructions, drawings, and procedure manualsStrong computer, math, writing, and problem-solving skillsExpert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices; knowledge of ISO 14971 and device-related compliance standardsKnowledge of lean manufacturing principlesSkills and AbilitiesPossess high level of energy.Strong verbal and written communications skills.Organized with strong record keeping and follow-up skills.Strong regard for exceptional customer service (internal/external), ability to address and resolve customer problems.Attention to detail in a fast-paced environmentAbility to work independently and take initiativeGood interpersonal, communication (both verbal and written)Additional InformationAll your information will be kept confidential according to EEO guidelines Show more details...
via Indeed schedule_type: Full-time
Packaging Engineer The Packaging Engineer will support multiple concurrent projects and is responsible for packaging configurations and processes related to new product launch, existing packaging improvements, and line extensions. This includes evaluating packaging configurations for feasibility in relation to validation (ISO 11607) and commercial success during Millstone’s launch process. The... Packaging Engineer will manage Millstone’s Fastlane Packaging Engineer

The Packaging Engineer will support multiple concurrent projects and is responsible for packaging configurations and processes related to new product launch, existing packaging improvements, and line extensions. This includes evaluating packaging configurations for feasibility in relation to validation (ISO 11607) and commercial success during Millstone’s launch process. The... Packaging Engineer will manage Millstone’s Fastlane Packaging to support new programs while continuously evaluating the Fastlane strategy to stay competitive in the industry. Additionally, this role will work cross functionally to support Millstone’s operations team with packaging related trouble shooting and cost reduction projects.

Principal competencies, responsibilities, and duties :

§ Technical knowledge and skills:

o Extensive Experience with sterile barrier packaging system designs consisting of sterile pouch and thermoformed tray packaging.

o Experience with Package Design Verification and Validation including Packaging Usability, Design Verification and Validation, Transportation and Handling testing, Package quality including sterile barrier testing (ISO 11607)

o Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards.

o Experience with Thermoforming, Heat Sealing, Impulse Sealing, Vacuum Flush Pouching, Cartoning, and label printing/ verification.

o Sterilization packaging processes such as aseptic filling and packaging for terminal sterilization using autoclave, VHP, EtO, Gamma, etc.

o Possess the ability to be actively involved in trouble-shooting packaging and process problems, coordinating with internal and external teams and resources.

o Able to guide others in the use of test equipment/tooling/processes.

o Ability to troubleshoot equipment.

Ability to read and interpret schematics and detailed mechanical drawings

§ Organizational skills

o Ability to multitask

o Detail Oriented

Effectively plans and manages time and deliver results on schedule

§ Math skills

o Basic math through Calculus

o Intermediate skills in Statistics

Ability to record and interpret test data, compile reports

§ Interpersonal skills

o Ability to interact with all levels of the facility

o Ability to interact with clients and interpret their needs

o Ability to negotiate with clients regarding projects, timelines, and processes

o Escort vendors within facility and provide technical expertise as needed

o Ability to work and interact in a team environment

o Ability to perform detailed engineering work without supervision

Ability to effectively communicate issues and solutions verbally and in writing

§ Work Ethic

o Get the job done attitude

o Able to meet or exceed established commitments

o Willingness to do what needs to be done to meet customer needs/timelines

Ability to change gears easily as priorities shift

Practical Experience (years and type required):

4-6 years engineering experience

A. Technical Qualifications or Specialized Certification:

Packaging Technology/ Engineering Degree

#IND123

Job Type: Full-time

Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Experience level:
• 4 years
• 6 years

Schedule:
• Monday to Friday

Work setting:
• In-person
• Manufacturing facility

Application Question(s):
• Will you now or in the future require visa sponsorship?

Work Location: In person
Show more details...